The clinical effects of leukocyte removal filters, cell savers and their combination on blood transfusion and organ damage during cardiac surgery

Completed

• Conditions: transfusion complications, organ damage, coagulation disorders; Injury, Occupational Diseases, Poisoning; Complications following infusion, transfusion and therapeutic injection

• Registration Number: ISRCTN58333401
• Lead Sponsor: niversity Medical Centre Groningen (UMCG) (The Netherlands)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25440265 2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/30610759

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-06-01
• Study Start: 2005-12-20
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

1. Adult patients scheduled for cardiac surgery
2. Informed consent

The study is not blinded, because intraoperative cell saving cannot be concealed by the size and noise of the apparatus. Blockwise randomisation will be employed to avoid imbalance. Numbered, sealed randomisation envelopes will be used. Randomisation will be registered centrally. The randomisation code will not be revealed to any of the participating investigators.

Exclusion Criteria

1. Patients with known coagulation disorders except from the use of aspirin or low molecular weight heparin given at least 10 hours before surgery
2. Patients under 18 years
3. Patients presenting for emergency operations

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
<br> 1. Length of stay in the intensive care unit and in the hospital<br> 2. Number of rethoracotomies (any re-exploration within 48 hours after the initial operation)<br> 3. Myocardial infarction (new Q-wave on the electrocardiogram [ECG] and creatine kinase [CK] greater than 180 U/l with creatine kinase myocardial bands [CK-MB] greater than 10% of total)<br> 4. Renal (serum creatinine greater than 1.5 baseline) and pulmonary dysfunction<br> 5. Peri-operative infections<br> 6. Costs of the interventions<br> 7. Coagulation disorders<br> 8. Markers of inflammation (leukocyte and granulocyte counts, interleukin-6, elastase, C-reactive protein, myeloperoxidase)<br>