Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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 (CPB).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Anticoagulants

Criteria

Inclusion Criteria:

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.

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Exclusion Criteria:

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

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