We expect that aprotinin will be better in reducing blood loss and transfusion requirements compared with tranexamic acid. However, tranexamic acid will be more cost effective and avoid the risk of anaphylactic shock at reexposeure seen with…
ID
Bron
Verkorte titel
Aandoening
Intra-operative medication trial.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Intraoperative and perioperative blood loss;<br>
2. Intraoperative and perioperative use of blood products.
Achtergrond van het onderzoek
Bleeding and the need foor blood transfusions are correlated with increased morbidity, mortality and higher costs. Aprotinin and tranexamic acid have shown to reduce borh blood loss and transfusion requirements during and after cardiac surgery. The efficacy and cost effectivity of tranexamic acid in comparison to aprotinin has been minimally investigated. The few controlled clinical trials that have been performed show a slight benefit of aprotinin over tranexamic acid.
The purpose of this study is to determine which of these pharmacological agents is most efficious and cost effective compared to standard treatment.
Doel van het onderzoek
We expect that aprotinin will be better in reducing blood loss and transfusion requirements compared with tranexamic acid. However, tranexamic acid will be more cost effective and avoid the risk of anaphylactic shock at reexposeure seen with aprotinin.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Group A will receive placebo;
Group B will receive high dose aprotinin;
Group C will receive tranexamic acid.
- All medications will be administered during surgery. Anesthetic and surgical procedures in all groups will be carried out according to standard care ;
- All patients will be observed until their discharge, during which time all measurements obtained during standard care will be recorded;
- One blood monster preoperative and four blood monsters will be taken postoperatively to asses for protein concentrations related to SIRS.
Publiek
Department of CardioThoracic Surgery,
room D6-53,
P.O. Box 9600
R.J.M. Klautz
Leiden 2300 RC
The Netherlands
+31 (0)71 5264022
r.j.m.klautz@lumc.nl
Wetenschappelijk
Department of CardioThoracic Surgery,
room D6-53,
P.O. Box 9600
R.J.M. Klautz
Leiden 2300 RC
The Netherlands
+31 (0)71 5264022
r.j.m.klautz@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of CPB.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Less than 18 years old;
2. Previous sternotomy;
3. Previous aprotinin therapy;
4. Known or suspected allergy to aprotinin;
5. Refusal to receive blood transfusion;
6. Abnormal perioperative coagulation profile for reasons other than anticoagulant therapy;
7. Treatment with antiplatelet agents within the 5 days before the operation;
8. Known bleeding disorder;
9. Pregnancy;
10. Scheduled for 3 or more procedures;
11. Emergency operations.
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 | NL224 |
NTR-old | NTR261 |
Ander register | : N/A |
ISRCTN | ISRCTN00157697 |