Status:
COMPLETED
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
Lead Sponsor:
Prothya Biosolutions
Conditions:
CPB
Oral Anticoagulant Therapy
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (C...
Detailed Description
The value of oral anticoagulants such as coumarin derivatives as a therapy and in the prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in the prevention of cere...
Eligibility Criteria
Inclusion
- age at least 18 years and due to undergo (semi-) acute cardiac surgery with a relatively stable haemodynamic condition.
- and body weight less than 100 kg and informed consent and patients well controlled with acenocoumarol, phenprocoumon or warfarin.
- \-
Exclusion
- patients with an overdose of acenocoumarol, phenprocoumon or warfarin (INR \> 7.8) and due to undergo (semi-) acute cardiac surgery hepatic insufficiency renal insufficiency anaphylactic reaction after administration of a blood product in the past disseminated intravascular coagulation (DIC) active thrombosis/pulmonary embolism intracardial thrombus patients treated with platelet inhibitors, except for aspirin (acetylsalicylic acid), who will be treated with aprotinine pregnancy breast-feeding
- \-
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00151853
Start Date
March 1 2002
End Date
September 1 2004
Last Update
December 7 2023
Active Locations (1)
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1
University Hospital Gasthuisberg
Leuven, Belgium, 3000