Intrauterine infusion of autologous platelet rich plasma (PRP) versus granulocyte colony stimulating factor (G-CSF) for thin endometrium in infertile women.

Start Date29 Mar 2024

Sponsor / Collaborator-

NCT04580563

/ CompletedNot ApplicableIIT

Prospective Randomized Versus Placebo Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients.
OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

Start Date22 Oct 2020

Sponsor / Collaborator

Les Hopitaux Universitaires de Strasbourg

NCT04623255

/ CompletedPhase 2IIT

A Randomised Controlled Trial of Plasma Exchange With Standard of Care Compared to Standard of Care Alone in the Treatment of Severe COVID-19 Infection (COVIPLEX)

The rationale in severe COVID19 infection is to undertake PEX to aid reduction of the hyperinflammation and reduce the morbidity and mortality to the lungs, but also systemically, such as the heart, kidneys and brain. A feasibility study of PEX therapy has been undertaken and confirmed a reduction in the inflammatory markers, no VTE/arterial events and normalisation of the renal function and cardiac function throughout the period of therapy. As plasma exchange is an intensive treatment modality, blocks of 5 daily PEX will be undertaken. Further blocks of PEX treatment can be initiated as dictated by the clinical and laboratory parameters. Unlike many therapeutic schedules, there is no immunosuppression associated with PEX; indeed, the resulting decrease in inflammatory markers were shown to be associated with an increase and sustained lymphocytes count.

Start Date16 Oct 2020

Sponsor / Collaborator

University College London

100 Clinical Results associated with Pooled Plasma (Human) (Octapharma )

100 Translational Medicine associated with Pooled Plasma (Human) (Octapharma )

100 Patents (Medical) associated with Pooled Plasma (Human) (Octapharma )

Literatures (Medical) associated with Pooled Plasma (Human) (Octapharma )

01 Jul 2025·Anaesthesia reports

Implementation of a maternity hospital rotational thromboelastometry ( ROTEM ^® ) guided transfusion strategy: a quality improvement study*

Article

Author: T. Drew ; M. Tahir ; R. M. O'Donovan ; L. Pentony ; S. R. Mir ; H. Tawfik

Summary:

A rotational thromboelastometry (ROTEM ® ) guided transfusion strategy for obstetrics was implemented at our institution in September 2022. The aim of the strategy was to facilitate timely, targeted administration of coagulation products based on viscoelastic haemostatic testing, thereby reducing unnecessary transfusions. To improve compliance with the ROTEM ® strategy, an electronic decision tool was developed and integrated into a smartphone application, supported by departmental education and training. We subsequently analysed data on 944 women who experienced postpartum haemorrhage ≥ 1500 ml over a 5‐year period, comparing 1 year of data after the formal introduction of the ROTEM ® ‐guided transfusion strategy (post‐ROTEM ® ) with the previous 4 years, when a conventional transfusion strategy was in place based on standard laboratory tests (pre‐ROTEM ® ). Following implementation, the annual use of fibrinogen concentrate, Octaplas ® (Octapharma Pharmazeutika GmbH, Vienna, Austria) and platelets to treat PPH ≥ 1500 ml decreased by 46%, 72% and 79%, respectively, yielding a cost saving of €51,738. Compliance with evidence‐based fibrinogen transfusion triggers improved significantly (84% vs. 23%) and empirical product use was eliminated. There was no statistically significant difference in the proportion of women who progressed to severe haemorrhage (≥ 2000 ml) between groups: 97/238 (40%) in the post‐ROTEM ® group vs. 312/706 (44%) in the pre‐ROTEM group (p = 0.35). This quality improvement initiative demonstrated that embedding a ROTEM ® ‐guided transfusion strategy into clinical workflows, supported by a decision tool and staff training, can enhance adherence to evidence‐based practice, reduce unnecessary coagulation product use and generate substantial cost savings, without adversely affecting clinical outcomes. These findings may inform institutions seeking to optimise transfusion strategies in obstetric haemorrhage through structured implementation approaches.

01 Feb 2025·TRANSFUSION MEDICINE

Validation of current commercially‐available devices to thaw pooled, solvent/detergent‐treated human plasma

Article

Author: Gareis, Michelle ; Heger, Andrea

Abstract:

Background:

Proper thawing procedures are required to preserve the quality of human fresh frozen plasma (FFP). octaplasLG (Octapharma AG, Switzerland) is a frozen solution of solvent/detergent (S/D)‐treated human plasma, produced to improve pathogen safety. This study aimed to validate the S/D plasma thawing process using the latest‐generation of commercially‐available thawing devices and to determine S/D plasma quality after thawing.

Study Design and Methods:

Thawing of S/D plasma units was investigated using a microwave oven (Transfusio‐therm 3000) and dry tempering systems (SAHARA 4 and Plasmatherm V). Times to defrost plasma and reach 30°C product temperature, using the 37°C thawing programmes, were defined for all devices. Thawed S/D plasma units were tested against product release parameters, as well as for hemostatic capacity tested indirectly via global coagulation parameters, coagulation factors, protease inhibitors and markers of activated coagulation.

Results:

The fastest thawing was observed using the microwave oven; S/D plasma units were defrosted after 2–3 min. All S/D plasma units thawed by the different devices using optimised thawing conditions were clear and free of solid and gelatinous particles, indicating no local overheating or protein denaturation. Coagulation factor and inhibitor activities and hemostatic capacity of S/D plasma were comparable when thawed by the three different devices. With each device, all product parameters were within product release specification levels after thawing.

Conclusions:

S/D plasma can be thawed using the Transfusio‐therm 3000, SAHARA 4 or Plasmatherm V thawing devices using the optimised settings defined for this plasma product, with no negative influence on plasma quality.

01 Dec 2022·Transfusion

Frozen and freeze‐dried solvent/detergent treated plasma: Two different pharmaceutical formulations with comparable quality

Article

Author: Heger, Andrea ; Gruber, Gerhard

Abstract:

Background:

OctaplasLG is a frozen solvent/detergent‐treated plasma product used for treating complex coagulation factor deficiencies or as substitution therapy in emergency situations where specific factor concentrates are not available. A new freeze‐dried (also known as lyophilized) form of OctaplasLG, referred as OctaplasLG Lyo (Octapharma AG, Switzerland) offers rapid reconstitution and more flexible storage conditions, improving logistics and utilization. This study compared the biochemical quality of OctaplasLG Lyo with OctaplasLG and single‐donor fresh frozen plasma units.

Study Design and Methods:

Three batches of OctaplasLG Lyo, manufactured for production process qualification, and 12 batches of OctaplasLG were provided by Octapharma AB (Sweden). Twelve units of fresh frozen plasma were collected by the local FDA‐licensed blood provider. All plasma samples were assessed for global coagulation parameters, coagulation factors and protease inhibitors, activation markers of coagulation and fibrinolysis, and important plasma proteins. Quality control assays were conducted in accordance with European Pharmacopeia requirements.

Results:

Frozen and freeze‐dried OctaplasLG demonstrated comparable quality profiles upon thawing or reconstitution. All coagulation factor and protease inhibitor activity parameters were in line with levels mandated by the European Pharmacopeia. Fresh frozen plasma units showed comparable coagulation factor activities, with higher protein S and plasmin inhibitor levels than the OctaplasLG products. Fresh frozen plasma parameters showed high lot‐to‐lot variations.

Discussion:

The two pharmaceutical forms of OctaplasLG (frozen and freeze‐dried) have comparable biochemical quality. Key features of OctaplasLG Lyo are rapid reconstitution time and storage flexibility, which may improve logistics and utilization, and have particular advantages in emergency situations and pre‐hospital settings.

News (Medical) associated with Pooled Plasma (Human) (Octapharma )

27 Feb 2024

·www.businesswire.com

Sepsis Drug Pipeline Research Report 2024: Insights from 30 Companies and 35 Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Sepsis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines. The assessment part of the report embraces, in depth Sepsis commercial assessment and clinical assessment of the pipeline products under development In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sepsis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve Sepsis. Sepsis Emerging Drugs Chapters This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sepsis Emerging Drugs Thymosin alpha 1: SciClone Pharmaceuticals Thymosin alpha 1, referred to as thymalfasin, is a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement. SciClone developed and launched Thymosin alpha 1, under the trade name Zadaxin, for the treatment of hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of COVID 2019 infections. Scientific and clinical studies have shown that Thymosin alpha 1 helps to stimulate and direct the body's immune response to eradicate infectious diseases, such as HBV, HCV, bacterial, and fungal infections; to fight certain cancers such as melanoma and liver cancer; and to enhance response to vaccines. Clinical trials have shown that Thymosin alpha 1 improves survival in patients in intensive care units being treated for sepsis from severe bacterial infections. The therapy is being evaluated in Phase III stage to treat Sepsis. Currently, the drug is in Phase III stage of its development for the treatment of sepsis. Enibarcimab: AdrenoMed AG Enibarcimab (HAM8101; former name: Adrecizumab) a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Enibarcimab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity. Enibarcimab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal. Currently, the drug is in Phase II stage of its development for the treatment of sepsis. M 6229: Matisse Pharmaceuticals Matisse's platform technology is based on the discovery that in many patients suffering from sepsis, proteins called histones are released by the innate immune system and dying cells into the blood stream, where they are toxic to other cells. Due to a self-enforcing cascade, people may die from organ failure within one or two days. Preclinical results have shown that by neutralizing the toxic histones with Matisse's product M6229, the negative cascade is terminated by neutralization of cationic histones by anionic M6229. Matisse claims to have identified an elegant solution for treating one of the major complications in sepsis by using a non-anticoagulant fraction of heparin called M6229 to neutralize toxic circulatory histones .Currently, the drug is in Phase I stage of its development for the treatment of sepsis. SNIPR 001: SNIPR Biome SNIPR001 is a novel, orally-administered antibiotic that is designed to precisely target difficult-to-treat bacterial infections. It is developed using SNIPR Biome's CRISPR-Guided VectorsT (CGVT Technology), which is designed to deliver CRISPR reagents into target bacterial cells. SNIPR001 is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome. It contains four CRISPR-armed phages that selectively target and eliminate E. coli strains that are resistant to fluoroquinolone, with demonstrated efficacy in animal disease models. Currently, the drug is in preclinical stage of its development for the treatment of sepsis. Sepsis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sepsis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs. Sepsis: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Sepsis Report Insights Sepsis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Sepsis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players SciClone Pharmaceuticals AdrenoMed AG Matisse Pharmaceuticals SNIPR Biome Tianjin Chase Sun Pharmaceutical Beijing Scitech-Mq Pharmaceuticals Recce Pharmaceuticals Inotrem Octapharma Shaperon Shionogi Pharmazz Seres Therapeutics Key Products Thymosin alpha 1 Enibarcimab M 6229 SNIPR 001 Kukoamine B ST-1830 RECCE 327 Nangibotide OctaplasLG HY209 Cefiderocol Centhaquine SER 155 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ixi7k5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Phase 1

02 Feb 2023

·www.businesswire.com

European Authorities Approve Lyophilized S/D Treated Plasma OctaplasLG® for Pre-Hospital Transfusion

LACHEN, Switzerland--( BUSINESS WIRE )--Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG ® - pharmaceutically-licensed S/D treated plasma for transfusion. The line extension, which will be marketed in Europe as a powder and solvent for solution for infusion, offers new and potentially life-saving treatment options in pre-hospital and emergency settings. “The European authorization of octaplasLG ® powder continues Octapharma's ongoing commitment to help prevent uncontrolled haemorrhage associated with trauma, which accounts for 30%-50% of all deaths in the first 24 hours" 1-5 , says Dr. Oliver Hegener, Vice President IBU Critical Care. Trauma results in 4.4 million deaths worldwide annually 6 , with uncontrolled bleeding being the major cause of potentially preventable death. Trauma-induced coagulopathy (TIC) is an early abnormal response characterised by hypocoagulation, in addition to acute blood loss, shock, hypothermia and metabolic acidosis, that begins soon after injury. Early - pre-hospital - administration of plasma has been shown to increase survival, compared with crystalloids, when pre-hospital transport was longer than 20 minutes. 7 Until now, access to early plasma transfusion was limited by logistic hurdles as well as a lack of available transfusion medicine in the pre-hospital setting for both for civilian and military patients. "octaplasLG ® powder, an AB universal plasma, can be stored at room temperature and reconstituted within minutes, representing a potentially lifesaving treatment option in emergency situations and in locations with limited frozen storage facilities and cold chain infrastructure required for regular FFP," explains Dr. Hegener. About octaplasLG ® Pharmaceutical grade human plasma for infusion with standardised quality and unique pathogen safety profiles due to Octapharma’s integrated pathogen elimination/inactivation concept. The standardised content is achieved by pooling between 630 and 1520 single plasma units from multiple carefully screened donors. Safety measures present during manufacturing include: Donor screening, immunoneutralisation, Solvent/detergent treatment and Ligand affinity chromatography for prion reduction. The product is approved for: Complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion. Substitution therapy in coagulation factor deficiencies, when a specific coagulation factor concentrate (e.g., factor V or factor XI) is not available for use or in emergency situations when a precise laboratory diagnosis is not possible. Rapid reversal of the effects of oral anticoagulants (coumarin or indanedione type) when a prothrombin complex concentrate is not available for use or administration of vitamin K is insufficient due to impaired liver function or in emergency situations. Potentially dangerous haemorrhages during fibrinolytic therapy, using e.g., tissue plasminogen activators, in patients who fail to respond to conventional measures. Therapeutic plasma exchange procedures, including those in thrombotic thrombocytopenic purpura (TTP). About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. References: 1. Bosch F, Angele MK, Chaudry IH. Gender differences in trauma, shock and sepsis. Mil Med Res. 2018;5(1):35. 2. Iapichino GE, Ponschab M, Cadamuro J, et al. Concentrated lyophilized plasma used for reconstitution of whole blood leads to higher coagulation factor activity, but unchanged thrombin potential compared with fresh-frozen plasma. Transfusion. 2017;57(7):1763-71. 3. Nguyen C, Bordes J, Cungi PJ, et al. Use of French lyophilized plasma transfusion in severe trauma patients is associated with an early plasma transfusion and early transfusion ratio improvement. J Trauma Acute Care Surg. 2018;84(5):780-5. 4. Moore EE, Moore HB, Kornblith LZ, et al. Trauma-induced coagulopathy. Nat Rev Dis Primers. 2021;7(1):30. 5. Johansson PI, Sorensen AM, Perner A, et al. Disseminated intravascular coagulation or acute coagulopathy of trauma shock early after trauma? An observational study. Crit Care. 2011;15(6): R272. 6. World Health Organization. Injuries and violence. 19 March 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/injuries-and-violence. Last accessed January 2023 . 7. Pusateri AE, Moore EE, Moore HB, et al. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020;155(2): e195085.

Drug Approval

24 Jan 2022

·www.biospace.com

As Omicron Spreads Nationally, Octapharma’s fibryga® & Octaplas™ Become Increasingly Important Replacement Therapies

Patient blood management strategies have become increasingly important during the COVID-19 pandemic as the medical community has confronted the effects of decreasing blood supply. In fact, the American Red Cross recently declared the nation’s first-ever national blood crisis with the omicron variant surge, placing ever greater demands on blood product supply nationwide.1 This press release features multimedia. View the full release here: As omicron has spread nationally, Octapharma’s fibryga® and Octaplas™ have become Increasingly important replacement therapies. (Photo: Business Wire) Medical providers should consider replacing cryoprecipitate and fresh frozen plasma with Octapharma USA’s Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution. In addressing the tightening supply of blood products, the College of American Pathologists TACT (Transfusion, Apheresis, and Cellular Therapy) Committee has recommended that hospital transfusion services consider replacing products such as cryoprecipitate, if supplies become depleted, with alternative human plasma products.2 Octaplas™ and fibryga® are in good supply and readily available. “The current blood shortage has created a need to utilize alternatives for plasma and cryoprecipitate, such as Octaplas™ and fibryga®,” said Melissa Cushing, M.D., an international expert in perioperative bleeding and patient blood management.3 “I have utilized a proactive approach to patient blood management that includes using these products to replace plasma and cryoprecipitate, as well as strict enforcement of transfusion guidelines and hosting blood drives.” Many factors can impact the blood products supply chain, such as the number of donors, seasonal factors, and the ability of blood services to adequately predict needs throughout the year.4 Awareness of appropriate blood products ordering can help clinicians manage supply chain disruptions. “The availability of Octapharma’s human plasma products affords our critical care partners the confidence to support patient needs,” said Octapharma USA President Flemming Nielsen. “At Octapharma, critical care medicine continues to be an important part of our therapeutic focus − and we are fully committed to supporting our healthcare partners with a reliable and sustainable product supply.” About fibryga® Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use, is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Fibryga® is not indicated for dysfibrinogenemia. Contraindications Fibryga® is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga® or its components. Warnings and Precautions Monitor patients for early signs of hypersensitivity or allergic reactions. If necessary, discontinue administration and institute appropriate treatment. Thrombotic events have been reported in patients receiving fibryga®. Treatment with human fibrinogen concentrate has been associated with thrombosis at target plasma fibrinogen levels that were below 150 mg/dL. The thrombotic risks may be greater when the target fibrinogen plasma level is 150 mg/dL. Weigh the benefits of administration versus the risks of thrombosis. Fibryga® is made from pooled human plasma. Products made from human plasma may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Events The most serious adverse reactions that may be observed with fibryga® are thromboembolic episodes and anaphylactic type reactions. The most common adverse reactions observed in more than one subject in clinical studies with fibryga® (>5% of subjects) were nausea, vomiting, pyrexia (fever) and thrombocytosis. About Octaplas™ Octaplas™ is a solvent/detergent (S/D) treated, pooled human plasma indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or who are undergoing cardiac surgery or liver transplantation; and plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP). Contraindications Octaplas™ is contraindicated in patients with immunoglobulin A (IgA) deficiency; severe deficiency of protein S; history of hypersensitivity to fresh frozen plasma or to plasma-derived products including any plasma protein; or a history of hypersensitivity reaction to Octaplas™. Warnings and Precautions Transfusion reactions can occur with ABO blood group mismatches. Administration of Octaplas™ must be based on ABO-blood group compatibility. High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure. Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin (also named plasmin inhibitor). Thrombosis can occur due to low levels of Protein S. Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas™ per kg per minute. Octaplas™ is made from human plasma and may carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Adverse Reactions The most common adverse reactions observed in ≥ 1% of patients included pruritus, urticaria, nausea, headache, paresthesia. Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Paramus, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit octapharmausa.com. REFERENCES 1 - Red Cross Declares First-ever Blood Crisis amid Omicron Surge, January 11, 2022. 2 - The College of American Pathologists. The coronavirus emergency and the US blood supply: College of American Pathologists Transfusion, Apheresis and Cellular Therapy Committee. March 27, 2020. 3 - Melissa Cushing, M.D. is a paid consultant for Octapharma. 4 - Jan Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60:2748–2752.

Immunotherapy

100 Deals associated with Pooled Plasma (Human) (Octapharma )

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypovolemia	United States	Octapharma Pharmazeutika Produktionsgesellschaft Mbh	17 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Congenital Thrombotic Thrombocytopenic Purpura	Phase 3	United States	Octapharma AG	01 May 2007
Shock, Septic	Phase 2	Denmark	Octapharma AG	15 Apr 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02253082 (VIPER-OCTA, Pubmed \| Anesth Analg)	Phase 4	-	57	OctaplasLG	ohfnmajuhg(mjwitwhizu) = lughkxfojq nafquuejxb (ruslqhrhxh )	Positive	01 Oct 2018
				Standard FFP	ohfnmajuhg(mjwitwhizu) = amvflkvphx nafquuejxb (ruslqhrhxh )
NCT01063595 (CTgov)	Phase 1	-	63	Octaplas LG (Octaplas LG)	imjduixlri(plbjrnwzxj) = nwtvoogyjb ypdeyclkfk (aeesltpuoa, 8.93) View more	-	01 May 2014
				Octaplas SD (Octaplas SD)	imjduixlri(plbjrnwzxj) = pbwnobcjnq ypdeyclkfk (aeesltpuoa, 8.75) View more

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