No registrations found.
ID
Source
Brief title
Health condition
Intra-operative medication trial.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Intraoperative and perioperative blood loss;
2. Intraoperative and perioperative use of blood products.
Secondary outcome
1. Rethoracotomies;
2. The total duration of each patient's stay in the operating room;
3. Length of stay in the ICU and hospital;
4. Development of SIRS/sepsis/MOF;
5. 30-day morbidity;
6. 30-day mortality;
7. Costs.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
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.
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
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
Inclusion criteria
Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of CPB.
Exclusion criteria
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.
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 | NL224 |
| NTR-old | NTR261 |
| Other | : N/A |
| ISRCTN | ISRCTN00157697 |