No registrations found.
ID
Source
Brief title
Health condition
general surgery patients, heart valve replacement, peri/post operative bleeding problems
algemene chirurgie patiënten, hartklep vervanging, peri/post operatieve bloedingsproblemen
Sponsors and support
P.I. CARIM
1st and 3rd funding
Intervention
Outcome measures
Primary outcome
Stop of bleeding after the therapy. The clinical situtation after the treatment will be compared with conventional coagulation tests (aPTT, PT, fibrinogen level).
Secondary outcome
Thrombin generation and thromboelastography measurements, measured with the CAT en TEG method.
Background summary
Patients with post/peri operative bleeding problems usually are transfused with 4 units of FFP, unfortunately this leads to dilutional coagulapathy due to the dilution effect of the transfusion itself. The administration of factor concentrates, especially fibrinogen, consists of only a small bolus injection. There is no dilution effect of this latter treatment, no dilutional coagulopahty will occur. Briefly, fibrinogen concentrates with FFP (only 2 units) together will be a better alternative in bleeding problems than the current 4 units of FFP.
Study objective
The combination of fibrinogen concentrate with FFP transfusion to patients with massive post/peri-operative bleeding problems is a better alternative than FFP transfusion alone, due to the prevention of dilutional coagulapathy.
Study design
Before and after the given therapy
Intervention
Comparing FFP transfusion in massive bleeding patients with the combination of fibrinogen and FFP/DDAVP
Department of Obstetrics and Gynecology,
CMC5, Y4.179,
P.O. Box 30001
M. Pampus, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
m.van.pampus@og.umcg.nl
Department of Obstetrics and Gynecology,
CMC5, Y4.179,
P.O. Box 30001
M. Pampus, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3616161
m.van.pampus@og.umcg.nl
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
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 (< 30C) or with a circulatory arrest
5. Patients with a fibrinogenlevel > 2 g/L
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1173 |
| NTR-old | NTR1218 |
| Other | Transfusion policy : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Mittermayr M et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery:the role of fibrinogen administration. Anesth Analg. 2007; 105