Clinical trial NCT01053169: Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Official title: Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Protein Disorders
Blood Loss, Surgical
Perioperative Care
Keywords: Coagulopathy
Perioperative bleeding
Prothrombin complex
Liver disease
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 445
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility 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)

Primary outcomes:
measure: Adequacy of stopping or preventing bleeding
timeFrame: Up to 24 hours after treatment
Secondary outcomes:
measure: Transfusions required
timeFrame: Up to 24 hours after treatment
measure: Clinical trigger for administration of the intervention
timeFrame: Up to 24 hours after treatment
measure: Mortality
timeFrame: Up to 24 hours after treatment
measure: International normalized ratio (INR)
timeFrame: From 3 hours before and up to 24 hours after treatment
measure: Prothrombin time (PT)
timeFrame: From 3 hours before and up to 24 hours after treatment
measure: Receipt of other blood products and /or hemostatic agents
timeFrame: Up to 24 hours after treatment
measure: Vital signs
timeFrame: From 3 hours before and up to 24 hours after treatment
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool
city: Cambridge
country: United Kingdom
facility: Addenbrokes
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Southhampton
country: United Kingdom
facility: Southhampton General Hospital
Study officials:
affiliation: The KD Haemophilia Centre & Haemostasis Unit, Royal Free NHS Trust
name: Pratima Chowdary, MRCP, FRCPath
role: PRINCIPAL_INVESTIGATOR
References: