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.
ID
Bron
Verkorte titel
Aandoening
general surgery patients, heart valve replacement, peri/post operative bleeding problems
algemene chirurgie patiënten, hartklep vervanging, peri/post operatieve bloedingsproblemen
Ondersteuning
P.I. CARIM
1st and 3rd funding
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Stop of bleeding after the therapy. The clinical situtation after the treatment will be compared with conventional coagulation tests (aPTT, PT, fibrinogen level).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Before and after the given therapy
Onderzoeksproduct en/of interventie
Comparing FFP transfusion in massive bleeding patients with the combination of fibrinogen and FFP/DDAVP
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1173 |
| NTR-old | NTR1218 |
| Ander register | Transfusion policy : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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