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Effects of transfusion of leukocyte-depleted erythrocytes in cardiac valve surgery on postoperative complications.


- candidate number1534
- NTR NumberNTR336
- ISRCTNISRCTN68522192
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR10-sep-2005
- Secondary IDsN/A 
- Public TitleEffects of transfusion of leukocyte-depleted erythrocytes in cardiac valve surgery on postoperative complications.
- Scientific TitleEffects of transfusion of leukocyte-depleted erythrocytes in cardiac valve surgery on postoperative complications.
- ACRONYMN/A
- hypothesisTo investigate the role and mechanisms of leukocytes in allogeneic erythrocyte concentrates on postoperative complications, as MODS, infections and death.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Heart surgery, Cardiac valve surgery
- Inclusion criteriaPatients undergoing valve surgery (+/- CABG).
- Exclusion criteriaPatients under 18 years of age, patients with medical indications for leucocyte-depleted erythrocytes and who received blood transfusions within previous 3 months.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-1999
- planned closingdate1-mei-2001
- Target number of participants496
- InterventionsRandomization to receive buffy-coat-depleted (PC) or leukocyte-depleted transfusions when necessary. Pre-operative, at arrival at ICU and day 1 postoperatively at ICU blood samples were obtained.
- Primary outcome90-days mortality and causes of deaths.
- Secondary outcome1. In-hospital mortality, 30- and 60-days mortality, onset and type of postoperative infections, onset and type of multiple-organ-dysfunction-syndrome (MODS), ICU-stay, hospital-stay and long-term survival. Pro-and anti-inflammatory cytokine profile, complement system activation and inflammatory mediators.
2. Cost-effective-analysis for the primary outcome.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. Y.M. Bilgin
- CONTACT for SCIENTIFIC QUERIESMD. Y.M. Bilgin
- Sponsor/Initiator Dutch Heart Foundation
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsCirculation. 2004 Jun 8;109(22):2755-60.
Transfus Med. 2005 Jun;15(3):209-17.
- Brief summaryThe primary outcome and some secondary outcomes are published. The analysis of blood samples are still continuing and the long-term analysis is still ungoing.
- Main changes (audit trail)
- RECORD10-sep-2005 - 20-mei-2008


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