Healthy male volunteers. Study assessing the effect of a single 50IU/Kg dose of Beriplex on the anticoagulant effect of Dabigatran. This is of interest when rapid reversal of its effect is mandated. E.g. in the case of Bleeding or when rapid surgical intervention is necessary.
Conditions
Interventions
Trade Name: Beriplex P/N 500
Product Name: Beriplex (Prothrombin complex concentrate)
Product Code: RVG 101094
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo:
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Healthy males • Age between 18 and 50 years • Weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether a single dose of Beriplex (PCC 50 IU/Kg) is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days. As measured by the shed blood and washed blood method. ;Secondary Objective: Not applicable;Primary end point(s): The shed blood method: during 4 minutes blood will be collected from a 5.0x1.0mm cut in skin of the volar surface of the forearm. Fibrinopeptide A will be measured as well as the total volume of blood collected. The washed blood method: during 15 minutes blood will be collected from a 3.5x1.0mm cut in the skin of the volar surface of the forearm. This is done by placing a plexiglas chamber over the wound that is continuously flushed with saline attached to a fraction collector filling a 96 well plate for spectrometry. The time untill bleeding stops (bleeding time) can be determined as well as the total amount of blood loss as the Area under the curve (AUC). ;Timepoint(s) of evaluation of this end point: This will be done at 4 timepoints: baseline, after the last dose of Dabigatran, 30 minutes after PCC, 6 hours after PCC. After cross-over this is repeated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): aPTT, PT, Diluted thrombin time (Hemoclot), Endogenous thrombin generation, pre- and post factor II, VII, IX, X;Timepoint(s) of evaluation of this end point: Baseline, after last dose of Dabigatran, immediately after PCC, 30 minutes after PCC, 1-2-4-6 hours after PCC, 24 hours after PCC. | — |
Countries
Netherlands
Contacts
Public ContactProf. dr. P.W. Kamphuisen
University Medical Center Groningen
Outcome results
None listed