UnknownPhase 2

Reversal of Dabigatran With Prothrombin Complex Concentrate

Netherlands12 participantsStarted 2015-01

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Inhibition of the anticoagulant effect of Dabigatran, assessed by the "shed and washed blood" methods

Timeframe: Before Dabigatran (Baseline, T= day-2), After Dabigatran / Before PCC (T= day 0), After Dabigatran / After PCC (T=40 min.), After Dabigatran / After PCC (T=360 min.)

Trial details

NCT IDNCT02463591

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Contact for this trial

Alexander C Stehouwer, MD

0031503610116 a.c.stehouwer@umcg.nl

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