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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22443

Enrollment

650

Registered

2005-09-07

Start date

2004-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The patients will be divided in 4 groups according to a randomization table. 1. In group I (n= 150) blood will be processed with a cell saver and transfused without leukocyte removal filter

2. In group II (n=150) blood will be processed with a cell saver and transfused through a leukocyte removal filter. 3. In group III (n=150) blood will be filtered with a leukocyte removal filter, bu

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The number of allogenic blood products used.	—

Secondary

Measure	Time frame
Length 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).	—

Measure

Time frame

Length 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).

—

Contacts

Public ContactJ.A.M. Hagenaars

University Medical Center Groningen (UMCG), Department of Anesthesiology, P.O. Box 30001

j.a.m.hagenaars@anest.umcg.nl+31 (0)50 3612341

Outcome results