Reversal of Dabigatran With Prothrombin Complex Concentrate

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate whether Prothrombin Complex Concentrate (PCC) is effective in reversing the anticoagulant effect of Dabigatran, as assessed by two modified skin-bleeding tests.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: Boehringer Ingelheim; CSL Behring
• Treatments: Dabigatran; Thrombin

Criteria

Inclusion Criteria:

• Healthy males

• Age between 18 and 50 years

• Weight <100 kg

• Signed informed consent

• eGFR ≥ 80ml/min*1.73m2

Exclusion Criteria:

• History of allergic reaction to blood products

• Current participation in any other investigational drug study or within the past 30 days

• Increased bleeding tendency or history of thrombosis

• Anticoagulant medication, platelet aggregation inhibitors or NSAIDs

• Use of any medication 14 days before start of dabigatran intake