Intervention pilot study with FFP or the combination of fibrinogen concentrate and FFP to patients with massive (post) operative bloodloss.

Intervention pilot study with FFP or the combination of fibrinogen concentrate and FFP to patients with massive (post) operative bloodloss. - Intervention pilot study with fibrinogen concentrate

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31952

Enrollment

100

Registered

2008-07-07

Start date

2009-02-09

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

Stollingsstoornissen/massaal bloedverlies transfusion policy and coagulation in case of massive bleeding

Interventions

DDAVP injection (standard therapy of cardiothoracic patients with massive post-operative bleeding problems) vs. an combination of DDAVP with fibrinogen concentrate. FFP transfusion (standard therapy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with massive bloodloss during surgery and coagulopathy, who are transfused with FFP according to actual guidelines. Cardiothoracic surgery patients after heart valve replacement with massive bloodloss after surgery.

Exclusion criteria

Exclusion criteria: No therapeutic anticoagulans other than inhibitors of platelet aggregation. Patients with active HIV-infection Patients received FFP or fibrinogen before the surgery Patient without informed consent

Design outcomes

Primary

Measure	Time frame
Primary study parameters are the amount of blood loss and the use of blood products.	—

Secondary

Measure	Time frame
Thrombin generation measurements and thromboelastograhy will be compared with conventional coagulation tests.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)