Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)

Completed

• Conditions: Coagulation Protein Disorders; Perioperative Care; Blood Loss, Surgical
• Interventions: Biological: Beriplex® P/N; Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N; Other: Fresh Frozen Plasma

• Registration Number: NCT01053169
• Lead Sponsor: CSL Behring

Brief Summary

Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

Not provided

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Exclusion Criteria

• Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
• Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prophylaxis Cohort	Fresh Frozen Plasma (FFP) and Beriplex® P/N	Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention
Prophylaxis Cohort	Fresh Frozen Plasma	Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention
Treatment Cohort	Fresh Frozen Plasma	Patients experiencing acute bleeding perioperatively
Prophylaxis Cohort	Beriplex® P/N	Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention
Treatment Cohort	Beriplex® P/N	Patients experiencing acute bleeding perioperatively
Treatment Cohort	Fresh Frozen Plasma (FFP) and Beriplex® P/N	Patients experiencing acute bleeding perioperatively

Primary Outcome Measures

Name	Time	Method
Adequacy of stopping or preventing bleeding	Up to 24 hours after treatment

Secondary Outcome Measures

Name	Time	Method
Vital signs	From 3 hours before and up to 24 hours after treatment
Clinical trigger for administration of the intervention	Up to 24 hours after treatment
Transfusions required	Up to 24 hours after treatment
International normalized ratio (INR)	From 3 hours before and up to 24 hours after treatment
Prothrombin time (PT)	From 3 hours before and up to 24 hours after treatment
Receipt of other blood products and /or hemostatic agents	Up to 24 hours after treatment
Mortality	Up to 24 hours after treatment

Trial Locations

Locations (6)

Royal Blackburn Hospital; 🇬🇧 Blackburn, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Addenbrokes; 🇬🇧 Cambridge, United Kingdom

Southhampton General Hospital; 🇬🇧 Southhampton, United Kingdom

Blackpool; 🇬🇧 Blackpool, United Kingdom