Prothrombin complex concentrate (Cofact ®) as a potential antidote for novel anticoagulants Dabigatran and Rivaroxaban.

Ability of prothrombin complex concentrate (Cofact ®) to reverse the anticoagulant effect of novel antithrombotic agents.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22423

Enrollment

Registered

2010-04-06

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Anticoagulants. Antidote for bleeding.

Interventions

Subjects will be divided into two groups. Subjects in group 1 will take Dabigatran 2dd 150 mg on day -2, -1 and 0. Subjects in group 2 will take Rivaroxaban 2dd 20 mg on day -2, -1 and 0. After the fi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy males between 18-50 year; 2. No medical history of thrombotic disease or bleeding disorders; 3. Normal physical examination and laboratory screen; 4. Negative HIV-1, hepatitis B and hepatitis C serology.

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.

Design outcomes

Primary

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

Contacts

Public ContactElise Eerenberg

Meibergdreef 9, Room F4.139

E.S.Eerenberg@amc.uva.nl+31 (0)20 5667516

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)