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

NCT ID: NCT01053169

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

445 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Coagulation Protein Disorders Blood Loss, Surgical Perioperative Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Prophylaxis Cohort

Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention

Beriplex® P/N

Intervention Type BIOLOGICAL

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

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

Intervention Type BIOLOGICAL

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.

Fresh Frozen Plasma

Intervention Type OTHER

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

Treatment Cohort

Patients experiencing acute bleeding perioperatively

Beriplex® P/N

Intervention Type BIOLOGICAL

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

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

Intervention Type BIOLOGICAL

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.

Fresh Frozen Plasma

Intervention Type OTHER

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

Interventions

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Beriplex® P/N

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Fresh Frozen Plasma

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

Intervention Type OTHER

Other Intervention Names

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Prothrombin complex concentrate Prothrombin Complex Concentrate

Eligibility Criteria

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Inclusion Criteria

For all cohorts:

•≥ 16 years of age

* Received treatment with:

* Beriplex® P/N
* or FFP and Beriplex® P/N (in subsequent order)
* or FFP only
* INR and/or PT results available in connection with administration of Beriplex® P/N or FFP:

* within 3 hours directly before and after administration of Beriplex® P/N or FFP

In case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products

Cohort P (Prophylaxis Group):

* Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy
* Coagulopathy (INR \> 1.4 and/or PT ≥ 3 sec of upper limit of normal \[ULN\])
* Any planned major or minimally invasive procedure, except liver transplantation

Cohort T (Treatment Group):

* Acute perioperative bleeding (as assessed by the investigator)

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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pratima Chowdary, MRCP, FRCPath

Role: PRINCIPAL_INVESTIGATOR

The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust

Locations

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Royal Blackburn Hospital

Blackburn, , United Kingdom

Site Status

Blackpool

Blackpool, , United Kingdom

Site Status

Addenbrokes

Cambridge, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Southhampton General Hospital

Southhampton, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1492

Identifier Type: OTHER

Identifier Source: secondary_id

BE1116_5001

Identifier Type: -

Identifier Source: org_study_id