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

NCT01053169 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 445

Last updated 2017-10-03

No results posted yet for this study

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.

Conditions

  • Coagulation Protein Disorders
  • Blood Loss, Surgical
  • Perioperative Care

Interventions

BIOLOGICAL

Beriplex® P/N

Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.

BIOLOGICAL

Fresh Frozen Plasma (FFP) and Beriplex® P/N

FFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis.

OTHER

Fresh Frozen Plasma

Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Pratima Chowdary, MRCP, FRCPath · The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053169 on ClinicalTrials.gov