Efficacy of Lyophilized Human Prothrombin Complex Concentrate on acute patients with hemorrhage: a single arm phase II study - Lyophilized Human Prothrombin Complex Concentrate on acute patients: a single arm phase II study

Start Date01 Jan 2018

Sponsor / Collaborator

Yokohama City University

CTR20130294 / CompletedPhase 3

人凝血酶原复合物（PCC）治疗血友病乙患者的疗效及安全性的多中心、开放性临床研究

[Translation] A multicenter, open-label clinical study on the efficacy and safety of human prothrombin complex (PCC) in the treatment of hemophilia B patients

观察人凝血酶原复合物（PCC）治疗血友病乙患者的疗效和安全性。

[Translation]

To observe the efficacy and safety of human prothrombin complex concentrate (PCC) in the treatment of hemophilia B patients.

Start Date07 Jan 2013

Sponsor / Collaborator

Shanxi Kangbao Biological Product Co. Ltd.

100 Clinical Results associated with Human Prothrombin Complex Concentrate(Shanxi Kangbao Biological Products)

100 Translational Medicine associated with Human Prothrombin Complex Concentrate(Shanxi Kangbao Biological Products)

100 Patents (Medical) associated with Human Prothrombin Complex Concentrate(Shanxi Kangbao Biological Products)

Literatures (Medical) associated with Human Prothrombin Complex Concentrate(Shanxi Kangbao Biological Products)

01 Dec 2020·Journal of Trauma and Acute Care SurgeryQ2 · MEDICINE

The effects of human prothrombin complex concentrate on hemorrhagic shock-induced lung injury in rats: Implications for testing human blood products in rodents

Q2 · MEDICINE

Article

Author: McCully, Belinda ; Trivedi, Alpa ; Pati, Shibani ; Schreiber, Martin A. ; Nair, Alison ; Potter, Daniel R. ; Miyazawa, Byron Y. ; Vivona, Lindsay R. ; Lin, Maximillian

BACKGROUNDHemorrhagic shock (HS) and trauma can result in an endotheliopathy of trauma, characterized by endothelial compromise, inflammation, and aberrant coagulation. Kcentra, a prothrombin concentrate, has been demonstrated to mitigate pulmonary vascular leak in a murine model of HS. We investigated the effects of Kcentra in a rat model of HS, to achieve physiologic endpoints of relevance.METHODSRats subjected to a grade intravenous splenic injury and controlled hemorrhage for 60 minutes were resuscitated with shed volumes of (1) Lactated Ringer’s (LR) solution, (2) LR + 20 IU/kg Kcentra, (3) LR + 50 IU/kg Kcentra, (4) rat fresh frozen plasma (RFFP), or (5) human fresh frozen plasma (HFFP). Blood was harvested for monitoring metabolic and coagulation function. Rat lungs were evaluated for lung injury and permeability.RESULTSAnimals resuscitated with LR displayed a significant increase in pulmonary vascular permeability (sham, 407.9 ± 122.4; shock + LR, 2040 ± 1462). Resuscitation with RFFP (606.5 ± 169.3) reduced leak; however, treatment with Kcentra (HS + Kcentra [20 IU/kg]: 1792 ± 903.4, HS + Kcentra [50 IU/kg]: 1876 ± 1103), and HFFP (1450 ± 533.2) had no significant effect on permeability. Kcentra modestly altered clotting parameters. Metabolic measures, such as lactate, pH, and base deficit, were restored to baseline levels by both RFFP and HFFP, but not Kcentra or LR.CONCLUSIONKcentra did not alter pulmonary vascular permeability, but modestly increased clotting potential in injured rats. This suggests that there may be a xenogenic reaction of human products in rats and that the effects of Kcentra on vascular stability may be distinct from its ability to modulate clotting. Our data indicate that the species chosen and utilized for in vivo preclinical testing of human derived blood products is of critical importance in determining their efficacy in animal models and is the primary impetus to communicate these results.

01 Jan 2018·TH Open

Anaphylaxis Following Human Prothrombin Complex Concentrate in a Child with Lupus Anticoagulant Hypoprothrombinemia Syndrome: A Cautionary Tale

Author: Beggs, Joanne ; Mediwake, Heshani ; Mason, Jane ; Robertson, Jeremy

AbstractA previously healthy 3-year-old girl presented with a short history of mucocutaneous bleeding and a spontaneous left knee hemarthrosis following a nonspecific viral gastroenteritis. Initial investigations for a bleeding disorder revealed a normal platelet count; however, coagulation studies revealed a prothrombin time (PT) of 25 seconds and an activated partial thromboplastin time (APTT) of 66 seconds (both prolonged). The APTT did not correct on mixing with normal plasma, and further testing confirmed the presence of a strong lupus anticoagulant (LA). One-stage assays of factor VIII, VII, and X were normal, but factor II was markedly reduced. Based on this distinct clinicopathological picture, a diagnosis of lupus anticoagulant hypoprothrombinemia syndrome (LAHS) was made. Due to the presence of a hemarthrosis, the patient was treated with clotting factor concentrate. Human prothrombin complex concentrate (PROTHROMBINEX-VF) was used as a source of factor II replacement; however, during the infusion the patient developed anaphylaxis necessitating resuscitation. The patient was observed without further factor replacement, and the bleeding symptoms resolved over several days. Within 3 weeks her PT and factor II had normalized but the APTT remained prolonged. After 6 months the coagulation profile had completely normalized and the LA was negative. It is unusual to require replacement of factor II in paediatric LAHS because bleeding is typically minor and self-limited. Anaphylaxis to clotting factor concentrates has not been previously reported in the context of LAHS, but is well described in patients with congenital factor IX deficiency (hemophilia B). Whilst the potential mechanism for anaphylaxis in our patient is unknown, it is recommended that human prothrombin complex concentrates should be used cautiously in paediatric LAHS.

01 Aug 2017·American Journal of TransplantationQ1 · MEDICINE

Prolonged Survival Following Pig-to-Primate Liver Xenotransplantation Utilizing Exogenous Coagulation Factors and Costimulation Blockade

Q1 · MEDICINE

Article

Author: Sachs, D H ; Hertl, M ; Fishman, J A ; Cosimi, A B ; Patel, M S ; Shah, J A ; Colvin, R B ; Wilkinson, R A ; Markmann, J F ; Vagefi, P A ; Rosales, I ; Louras, N J ; Elias, N ; Navarro-Alvarez, N

Since the first attempt of pig-to-primate liver xenotransplantation (LXT) in 1968, survival has been limited. We evaluated a model utilizing α-1,3-galactosyltransferase knockout donors, continuous posttransplant infusion of human prothrombin concentrate complex, and immunosuppression including anti-thymocyte globulin, FK-506, methylprednisone, and costimulation blockade (belatacept, n = 3 or anti-CD40 mAb, n = 1) to extend survival. Baboon 1 remained well until postoperative day (POD) 25, when euthanasia was required because of cholestasis and plantar ulcers. Baboon 2 was euthanized following a seizure on POD 5, despite normal liver function tests (LFTs) and no apparent pathology. Baboon 3 demonstrated initial stable liver function but was euthanized on POD 8 because of worsening LFTs. Pathology revealed C4d positivity, extensive hemorrhagic necrosis, and a focal cytomegalovirus inclusion. Baboon 4 was clinically well with stable LFTs until POD29, when euthanasia was again necessitated by plantar ulcerations and rising LFTs. Final pathology was C4d negative and without evidence of rejection, inflammation, or thrombotic microangiopathy. Thus, nearly 1-mo rejection-free survival has been achieved following LXT in two of four consecutive recipients, demonstrating that the porcine liver can support life in primates for several weeks and has encouraging potential for clinical application as a bridge to allotransplantation for patients with acute-on-chronic or fulminant hepatic failure.

100 Deals associated with Human Prothrombin Complex Concentrate(Shanxi Kangbao Biological Products)

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Indication	Country/Location	Organization	Date
Hemophilia B	CN	Shanxi Kangbao Biological Product Co. Ltd.	17 Sep 2019

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