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Reversal of Dabigatran With Prothrombin Complex Concentrate

NCT02463591 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-05-12

No results posted yet for this study

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.

Conditions

  • Drug Action Reversal

Interventions

DRUG

Beriplex

Beriplex 50 IU/Kg i.v. , single dose.

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • CSL Behring

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Pieter Willem Kamphuisen, Prof. Dr. · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02463591 on ClinicalTrials.gov