Prothrombin

Generic Name: Prothrombin

Brand Names: Balfaxar, Beriplex, Kcentra, Octaplex

Drug Type: Biotech

Chemical Formula: -

CAS Number: 9001-26-7

Unique Ingredient Identifier: 8FB1K07F16

Background: Prothrombin Complex Concentrate (Human), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.

Indication: For use in the emergency reversal of coagulation factor deficiency in patients receiving vitamin K antagonist therapy. Prothrombin is administered as part of a cocktail containing several coagulation factors.

Associated Conditions: Bleeding, Vitamin K antagonist induced major bleeding

Associated Therapies: -

Clinical Trials

Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.

Not yet recruiting

Conditions: Hemorrhagic Disorders
Extrinsic Pathway Factor Deficiency
Hepatocellular Insufficiency With Coagulopathy

Interventions: Biological: Prothrombin

First Posted Date: 2024-11-26

Last Posted Date: 2024-11-26

Lead Sponsor: University Hospital, Strasbourg, France

Target Recruit Count: 100

Registration Number: NCT06705829

Locations: 🇫🇷
Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie, Strasbourg, France

Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure

Not yet recruiting

Conditions: Significant Bleeding Risk
Vitamin K-Dependent Coagulation Defect

Interventions: Drug: Balfaxar
Drug: Kcentra

First Posted Date: 2024-05-28

Last Posted Date: 2024-05-28

Lead Sponsor: Octapharma

Target Recruit Count: 3574

Registration Number: NCT06429787

Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery

Phase 3

Completed

Conditions: Bleeding Cardiac Surgery Patients

Interventions: Drug: Octaplex
Drug: Frozen Plasma Product, Human

First Posted Date: 2022-08-31

Last Posted Date: 2024-07-25

Lead Sponsor: Octapharma

Target Recruit Count: 419

Registration Number: NCT05523297

Locations: 🇺🇸
Duke University Health System, Durham, North Carolina, United States
🇨🇦
University of British Columbia and Vancouver Coastal Health Authority, Vancouver, British Columbia, Canada
🇨🇦
Sunnybrook Hospital, Toronto, Ontario, Canada

and more 10 locations

Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor

Phase 3

Recruiting

Conditions: Acute Major Bleeding

Interventions: Drug: Octaplex

First Posted Date: 2021-04-30

Last Posted Date: 2024-12-13

Lead Sponsor: Octapharma

Target Recruit Count: 260

Registration Number: NCT04867837

Locations: 🇪🇸
Hospital Universitario 12 de Octubre, Madrid, Spain
🇹🇷
SBU Adana City Education and Research Hospital, Adana, Turkey
🇹🇷
Mersin University Faculty of Medicine, Mersin, Turkey

and more 55 locations

Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation

Phase 3

Recruiting

Conditions: Heart Disease End Stage
Heart Failure，Congestive

Interventions: Drug: Frozen Plasma Product, Human
Drug: Kcentra

First Posted Date: 2017-11-14

Last Posted Date: 2024-01-08

Lead Sponsor: Kathirvel Subramaniam

Target Recruit Count: 60

Registration Number: NCT03341156

Locations: 🇺🇸
Upmc Presbyterian Montefiore Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
UPMC Presbyterian Shadyside, Pittsburgh, Pennsylvania, United States

Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

Phase 3

Completed

Conditions: Significant Bleeding Risk

Interventions: Drug: Beriplex P/N (Kcentra)
Drug: Octaplex

First Posted Date: 2016-04-15

Last Posted Date: 2023-03-08

Lead Sponsor: Octapharma

Target Recruit Count: 208

Registration Number: NCT02740335

Locations: 🇺🇦
Octapharma Research Site, Zhytomyr, Ukraine
🇧🇬
Octapharma Study Site, Sofia, Bulgaria
🇬🇪
Octapharma Research Location - Tbilisi, Tbilisi, Georgia

and more 5 locations

Reversal of Dabigatran With Prothrombin Complex Concentrate

Phase 2

Conditions: Drug Action Reversal

Interventions: Drug: Beriplex

First Posted Date: 2015-06-04

Last Posted Date: 2016-05-12

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 12

Registration Number: NCT02463591

Locations: 🇳🇱
University Medical Centre, Groningen, Netherlands

Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra

Phase 1

Completed

Conditions: Thrombosis

Interventions: Drug: Kcentra
Drug: Apixaban
Drug: Placebo

First Posted Date: 2014-10-21

Last Posted Date: 2016-06-07

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 12

Registration Number: NCT02270918

Locations: 🇺🇸
Thomas Jefferson University Hosptial, Philadelphia, Pennsylvania, United States

Prev
1
Next

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy