The clinical effects of leukocyte removal filters, cellsavers and their combination on blood transfusion and organ damage during cardiac surgery.
- Registration Number
- NL-OMON22443
- Lead Sponsor
- Anesthesiology dpt University medical center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
In this randomized prospective unblinded multicenter study 600 adult patients scheduled for cardiac surgery will be included after informed consent.
The study is not blinded, because intraoperative cell saving cannot be concealed by the size and noise of the apparatus. Blockwise randomization will be employed to avoid imbalance. Numbered, sealed randomisation envelopes will be used. Randomization will be registered centrally. The randomization code will not be revealed to any of the participating investigators.
Excluded are patients with known coagulation disorders except from the use of aspirin or low molecular weight heparin given at least 10 hours before surgery. Patients under 18 years or patients presenting for emergency operations are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of allogenic blood products used.
- Secondary Outcome Measures
Name Time Method ength of stay in the intensive care unit and in the hospital, number of rethoracotomies (any re-exploration within 48 hrs after the initial operation), myocardial infarction (new Q-wave on the ECG and CK>180 U/l with CK-MB>10% of total), renal (serum creatinin >1.5 baseline) and pulmonary dysfunction, perioperative infections, costs of the interventions, coagulation disorders and markers of inflammation (leukocyte and granulocyte counts, interleukin-6, elastase, c-reactive protein, myeloperoxidase).