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

Blood Loss, Surgical Clinical Trial

Official title:

Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053169
• Other study ID #: BE1116_5001
• Secondary ID: 1492
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: October 2, 2017
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2017
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria (All):

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)

Related Conditions & MeSH terms

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

Intervention

Biological:
• Beriplex® P/N
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	Blackpool	Blackpool
United Kingdom	Addenbrokes	Cambridge
United Kingdom	Royal Free Hospital	London
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Southhampton General Hospital	Southhampton

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of stopping or preventing bleeding		Up to 24 hours after treatment
Secondary	Transfusions required		Up to 24 hours after treatment
Secondary	Clinical trigger for administration of the intervention		Up to 24 hours after treatment
Secondary	Mortality		Up to 24 hours after treatment
Secondary	International normalized ratio (INR)		From 3 hours before and up to 24 hours after treatment
Secondary	Prothrombin time (PT)		From 3 hours before and up to 24 hours after treatment
Secondary	Receipt of other blood products and /or hemostatic agents		Up to 24 hours after treatment
Secondary	Vital signs		From 3 hours before and up to 24 hours after treatment

External Links

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