ABILITY OF PROTHROMBIN COMPLEX CONCENTRATE (COFACT ®) TO REVERSE THE ANTICOAGULANT EFFECT OF NOVEL ANTITHROMBOTIC AGENTS

ABILITY OF PROTHROMBIN COMPLEX CONCENTRATE (COFACT ®) TO REVERSE THE ANTICOAGULANT EFFECT OF NOVEL ANTITHROMBOTIC AGENTS - Cofact study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33208

Enrollment

Registered

2009-11-23

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

anticogulant therapy bleeding

Interventions

Administration of Rivaroxaban or Dabigatran Administration of Prothrombin Complex Concentrate or Placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males between 18-50 year will be recruited.

Exclusion criteria

Exclusion criteria: Subjects will have no medical history of thrombotic disease or bleeding disorders. They must have a normal physical examination and laboratory screen. They will not use any medication at least 14 days before the study days.

Design outcomes

Primary

Measure	Time frame
The primary outcome is activation and inhibition of coagulation, as reflected by coagulation tests.	—

Secondary

Measure	Time frame
none	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)