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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 445

Contacts and Locations

Study Locations

• United Kingdom
  • Blackburn, United Kingdom
    • Royal Blackburn Hospital
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool
  • Cambridge, United Kingdom, CB23 3RE
    • Addenbrokes
  • London, United Kingdom
    • Royal Free Hospital
  • Plymouth, United Kingdom
    • Derriford Hospital
  • Southhampton, United Kingdom
    • Southhampton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coagulopathy due to liver disease or other conditions requiring correction of coagulopathy who require surgical or diagnostic intervention and patients experiencing acute bleeding perioperatively

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylaxis Cohort; Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention	Biological: Beriplex® P/N; Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.; Other Names: Prothrombin complex concentrate; 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 Names: Prothrombin Complex Concentrate; Other: Fresh Frozen Plasma; Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
Treatment Cohort; Patients experiencing acute bleeding perioperatively	Biological: Beriplex® P/N; Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.; Other Names: Prothrombin complex concentrate; 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 Names: Prothrombin Complex Concentrate; Other: Fresh Frozen Plasma; Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adequacy of stopping or preventing bleeding	Up to 24 hours after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Transfusions required	Up to 24 hours after treatment
Clinical trigger for administration of the intervention	Up to 24 hours after treatment
Mortality	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
Vital signs	From 3 hours before and up to 24 hours after treatment

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Principal Investigator: Pratima Chowdary, MRCP, FRCPath, The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 20, 2010
• First Submitted That Met QC Criteria: January 20, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Liver disease; Coagulopathy; Perioperative bleeding; Prothrombin complex
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Blood Coagulation Disorders; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Coagulation Protein Disorders; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: BE1116_5001; 1492 (Other Identifier: CSL Behring)