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Intervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems

Intervention pilot with fibrinogen concentrate and the combination of fibrinogen concentrate with FFP in patients with massive post/peri-operative bleeding problems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24904
Enrollment
100
Registered
2008-01-31
Start date
2008-02-01
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

general surgery patients, heart valve replacement, peri/post operative bleeding problems algemene chirurgie patiënten, hartklep vervanging, peri/post operatieve bloedingsproblemen

Interventions

Comparing FFP transfusion in massive bleeding patients with the combination of fibrinogen and FFP/DDAVP

Sponsors

dr. JWM. Heemskerk P.I. CARIM
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. General surgery patients with massive peri-operative bloodloss, with an indication of receiving 4 units of FFP according to current guidelines. 2. Cardiothoracic surgery patients after heart valve replacement who met the criteria of increased bloodloss and indication for DDAVP.

Exclusion criteria

Exclusion criteria: 1. No other therapeutical anti-thrombotica are given, other than platelet-aggregation inhibitors 2. Patients with active HIV-infection 3. Patients who received FFP or fibrinogen just before the surgery 4. Patients who are hypotherm ( 2 g/L

Design outcomes

Primary

MeasureTime frame
Stop of bleeding after the therapy. The clinical situtation after the treatment will be compared with conventional coagulation tests (aPTT, PT, fibrinogen level).

Secondary

MeasureTime frame
Thrombin generation and thromboelastography measurements, measured with the CAT en TEG method.

Contacts

Public ContactM. Pampus, van

University Medical Center Gronigen (UMCG), Department of Obstetrics and Gynecology, CMC5, Y4.179, P.O. Box 30001

m.van.pampus@og.umcg.nl+31 (0)50 3616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)