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Evaluation of BE1116 (4F-PCC) in patients with traumatic injury

Jeffry Nahmias


A Study On:

  • Other

Status:

  • Open

Eligibility

Blood Coagulation Disorders
Acute Major Bleeding
18 Years and older (Adult, Older Adult )

Official Title

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients with Traumatic Injury and Confirmed or Suspected Acute Major Bleeding Predicted to Receive a Large Volume Blood Product Transfusion.

Details

The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate correction of INR (International Normalized Ratio)and to stop an acute major bleeding.


Eligibility

You can join if...

Inclusion Criteria:

  1. Male and female subjects greater than or equal to 18 years
  2. Subjects who have received oral vitamin K-antagonist therapy
  3. Subjects who have acute major bleeding, defined as one of the following: life-threatening or potentially life-threatening, acute bleeding associated with a fall in hemoglobin (Hb) level greater than or equal to 2g/dL, bleeding requiring blood product transfusion
  4. INR greater than or equal to 2 within 3 hours before start of study treatment
  5. Informed consent has been obtained

Exclusion Criteria:

  1. Expected survival of less than 3 days, or expected surgery in less than 1 day
  2. Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control the acute bleeding event
  3. Use of unfractionated or low molecular weight heparin use from 24 hours prior to enrollment or expected need within 24 hours after start of infusion
  4. For patients with ICH: Glasgow coma score (GCS) < 7; intracerebral hematoma volume > 30cc as assessed by ABC/21; for subdural hematomas: maximum thickness greater than or equal to 10 mm, midline shift greater than equal 5 mm; for subarachnoid hemorrhage: any evidence of hydrocephalus; infratentorial ICH location; epidural hematomas; intraventricular extension of hemorrhage; modified Rankin score (mRS) of >3 prior to ICH
  5. History of thrombotic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within 3 months of enrollment
  6. Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies
  7. Suspected or confirmed sepsis at time of enrollment
  8. Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study
  9. Large blood vessel rupture (e.g. in advanced cancer patient)
  10. Pre-existing progressive fatal disease with a life expectancy of less than 2 months
  11. Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia
  12. Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study
  13. Presence or history of hypersensitivity to components of the study medication
  14. Pregnant or breast-feeding women
  15. Prior inclusion in this study or any other CSL Behring-sponsored Beriplex study

Get in touch with our study team