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

CSL Behring

Status: Completed

Conditions: Coagulation Protein Disorders; Perioperative Care; Blood Loss, Surgical

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01053169

1492

BE1116_5001

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

445 participants in 2 patient groups

Prophylaxis Cohort

Description:

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

Treatment:

Biological: Beriplex® P/N

Other: Fresh Frozen Plasma

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

Treatment Cohort

Description:

Patients experiencing acute bleeding perioperatively

Treatment:

Biological: Beriplex® P/N

Other: Fresh Frozen Plasma

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