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

NCT01053169 | Completed

• 2 other identifiers: BE1116_50011492
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 6

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.

Conditions

Coagulation Protein Disorders; Blood Loss, Surgical; Perioperative Care

Keywords

Coagulopathy; Perioperative bleeding; Prothrombin complex; Liver disease

Outcome Measures

Primary Outcomes (1)

• Adequacy of stopping or preventing bleeding

  Up to 24 hours after treatment

Secondary Outcomes (7)

• 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

Study Arms (2)

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; Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N; Other: Fresh Frozen Plasma

Treatment Cohort

Patients experiencing acute bleeding perioperatively

Biological: Beriplex® P/N; Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N; Other: Fresh Frozen Plasma

Interventions

Beriplex® P/N BIOLOGICAL

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

Also known as: Prothrombin complex concentrate

Prophylaxis Cohort; Treatment Cohort

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

Also known as: Prothrombin Complex Concentrate

Prophylaxis Cohort; Treatment Cohort

Fresh Frozen Plasma OTHER

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

Prophylaxis Cohort; Treatment Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (6)

Royal Blackburn Hospital

Blackburn, United Kingdom

Location

Blackpool

Blackpool, FY3 8NR, United Kingdom

Location

Addenbrokes

Cambridge, CB23 3RE, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Southhampton General Hospital

Southhampton, United Kingdom

Location

MeSH Terms

Conditions

Coagulation Protein Disorders; Blood Loss, Surgical; Hemostatic Disorders; Liver Diseases

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Pratima Chowdary, MRCP, FRCPath

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: October 3, 2017

Record last verified: 2017-10

Locations

GB (6)