A blood coagulation factor replacement product for use in the treatment or prophyl of bleedings

A technology for coagulation factor and coagulation factor deficiency, applied in the field of coagulation factor replacement products, can solve different problems

Pending Publication Date: 2019-08-09
CSL BEHRING GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Careful consideration of the above steps will result in a markedly different approach to the use of PCC compared to established practice of emergency vitamin K antagonist reversal

Method used

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  • A blood coagulation factor replacement product for use in the treatment or prophyl of bleedings
  • A blood coagulation factor replacement product for use in the treatment or prophyl of bleedings
  • A blood coagulation factor replacement product for use in the treatment or prophyl of bleedings

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0335] Example - Rabbit Model

[0336] Hemostatic efficacy of PCC in a rabbit model of hemodilution-mediated bleeding and tissue injury

[0337] Materials and methods

[0338] animal

[0339] 3-4 month-old female CHB rabbits (Manfred Bauer, Neuenstein-Lohe, Germany) with a body weight of 2.8-4.0kg were placed in a wire cage, 21-23°C and 50% relative humidity, 12h / 12h light-dark cycle. Animals were provided with tap water ad libitum and fed rabbit pellets ( Deutsche Tiernahrung Cremer GmbH & Co. KG, Duesseldorf, Germany). All animals were cared for in accordance with the European Convention for the Protection and Research of Animals and the study was approved by the organizational ethics committee.

[0340] hemodilution

[0341] All treatments were performed in anesthetized animals. Anesthesia was induced by a combination of ketamine and xylazine and maintained by inhaled isoflurane anesthesia. Animals were then intubated and placed on a ventilator (Heyer Access, Heyer...

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Abstract

The invention pertains to a blood coagulation factor replacement product for use in the treatment or prophylaxis of bleedings of patients having an acquired coagulation factor deficiency or for use inthe treatment or prophylaxis of bleedings of patients having a congenital deficiency of a coagulation factor. Said product comprises at least isolated prothrombin (Factor II) and isolated Antithrombin III (ATIII), whereby the molar ratio between ATIII to Factor II is at least 1:30. By administration of said product the patient's risk for a thromboembolic complication is reduced.

Description

[0001] field of invention [0002] The present invention relates to coagulation factor replacement products for treating or preventing bleeding in patients with acquired coagulation factor deficiency, or for treating or preventing bleeding in patients with congenital coagulation factor deficiency. [0003] Background of the invention [0004] Prothrombin complex concentrate (PCC) is recommended in preference to other treatments such as therapeutic plasma for emergency reversal of vitamin K antagonists (Tazarourte K et al (EPAHK Research). Crit Care 2014;18(2) :R81). PCCs have also been used for many years in Europe, where their approval is not limited to vitamin K antagonist reversal - they are broadly approved "for the treatment and prevention of bleeding in acquired deficiencies of the prothrombin complex coagulation factor". PCC contains three or four clotting factors (factors II, IX, and X, with or without factor VII) and, depending on the formulation, low doses of clottin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61K38/36A61K38/48A61P7/00
CPCA61K38/00A61K38/36A61K38/48A61P7/00A61K38/4846A61K38/38A61K31/727A61P7/04A61K2300/00A61P7/02A61K38/385A61K38/4833C12Y304/21005C12Y304/21021C12Y304/21022C12Y304/21038
Inventor E·赫佐格G·霍赫莱特纳O·格罗特克
Owner CSL BEHRING GMBH
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