Healthy male subjects between 18 and 50 year who have no medical history of thrombotic disease or bleeding disorders will be included in the study. They must have a normal physical examination and laboratory screen tests. They will not use any medication at least 14 days before the study days.
Conditions
Interventions
Intravenous administration of PCC (Cofact) 25 IU/kg or PCC (Cofact) 37.5 IU/kg or placebo (saline).
Sponsors
S. Middeldorp
Academic Medical Center
Meibergdreef 9
Amsterdam
s.middeldorp@amc.uva.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects as documented by laboratory screen tests (including HIV/HBV/HCV screening), personal medical history and normal physical examination; 2. Age ≥18 years, < 50 years; 3. No personal history of thrombotic disease/bleeding disorders; 4. No significant family history of thrombotic disease/bleeding disorders, such as recurrent thrombotic/bleeding events or thrombotic/bleeding events in the absence of any risk factors; 5. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction to blood products; 2. Current participation in any other investigational drug study or within the past 30 days; 3. Presence of any condition that, as judged by the investigator, would place the subject at increased risk of harm if he participated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the reversal (normalisation) of coagulation assays, at the end of oral f-Xa inhibitor administration and after the infusion of PCC or placebo. | — |
Contacts
Public ContactS. Middeldorp
Academic Medical Center (AMC), Department of Vascular Medicine, F4-276, P.O. Box 22660
Outcome results
None listed