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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01053169
First received: January 20, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Coagulation Protein Disorders
Blood Loss, Surgical
Perioperative Care
Biological: Beriplex® P/N
Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N
Other: Fresh Frozen Plasma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Adequacy of stopping or preventing bleeding [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transfusions required [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • Clinical trigger for administration of the intervention [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • International normalized ratio (INR) [ Time Frame: From 3 hours before and up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • Prothrombin time (PT) [ Time Frame: From 3 hours before and up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • Receipt of other blood products and /or hemostatic agents [ Time Frame: Up to 24 hours after treatment ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: From 3 hours before and up to 24 hours after treatment ] [ Designated as safety issue: No ]

Enrollment: 445
Study Start Date: May 2010
Study Completion Date: January 2012
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Prothrombin Complex Concentrate
Other: Fresh Frozen Plasma
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053169

Locations
United Kingdom
Royal Blackburn Hospital
Blackburn, United Kingdom
Blackpool
Blackpool, United Kingdom, FY3 8NR
Addenbrokes
Cambridge, United Kingdom, CB23 3RE
Royal Free Hospital
London, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Southhampton General Hospital
Southhampton, United Kingdom
Sponsors and Collaborators
CSL Behring
Investigators
Principal Investigator: Pratima Chowdary, MRCP, FRCPath The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust
  More Information

Additional Information:
No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01053169     History of Changes
Other Study ID Numbers: BE1116_5001, 1492
Study First Received: January 20, 2010
Last Updated: June 13, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by CSL Behring:
Coagulopathy
Perioperative bleeding
Prothrombin complex
Liver disease

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Coagulation Protein Disorders
Pathologic Processes
Intraoperative Complications
Blood Coagulation Disorders
Hematologic Diseases
Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014