Reversal of oral direct factor Xa inhibitors rivaroxaban and apixaban by two different dosages of prothrombin complex concentrate (Cofact®)

Reversal of oral direct factor Xa inhibitors rivaroxaban and apixaban by two different dosages of prothrombin complex concentrate (Cofact®) - Reversal of novel oral anticoagulants by prothrombin complex concentrate

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37035

Enrollment

Registered

2012-11-27

Start date

2013-02-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

use of anticoagulation

Interventions

Intravenous administration of PCC (Cofact) 25 IU/kg or PCC (Cofact) 37.5 IU/kg or placebo (saline)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Healthy male subjects as documented by laboratory screen tests (including HIV/HBV/HCV screening), personal medical history and normal physical examination. * Age *18 years,

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. * 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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)