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Transfusion induced complications = transfusion associated complications ? study.


- candidate number1507
- NTR NumberNTR309
- ISRCTNISRCTN48093674
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleTransfusion induced complications = transfusion associated complications ? study.
- Scientific TitleThe effects of leukocyte filtered versus buffy coat depleted erythocyte transfusions in major surgery patients.
- ACRONYMTACTICS
- hypothesisDoes removal of allogeneic white blood cells by filtration reduce postoperative complications?
- Healt Condition(s) or Problem(s) studiedComplications, Blood transfusions
- Inclusion criteriaAcute aneurysm-, elective aneurysm-, orthopaedic- and large gastro-intestinal surgery patients.
- Exclusion criteria1. Under 18 years of age;
2. Transfusions received within 3 months prior to inclusion;
3. Pre existing medical indication for filtered red blood cell transfusions.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-mrt-2000
- planned closingdate31-dec-2001
- Target number of participants1548
- InterventionsTransfusions of filtered red blood cell concentrates vs. transfusion of stored buffy coat depleted red blood cell concentrates.
- Primary outcomePostoperative:
1. In-hospital mortality;
2. Duration of intensive care stay.
- Secondary outcome1. Postoperative multi organ failure;
2. Postoperative infections;
3. Length of hospital stay;
4. Costs/benefits of universal leukocyte depletion for the Dutch health care;
5. Role of perioperative medication;


Follow up
1. Long term survival;
2. Cancer recurrence in GI patients;
3. Predictive role of cytokines and related genes.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.A. Hilten, van
- CONTACT for SCIENTIFIC QUERIESDr. J.A. Hilten, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Bloodbank Amsterdam
- Publications1. BMJ 2004; 328:1281-4
2. Ned Tijdschrift voor Hematologie 2005; 2:140-7
- Brief summaryThe aim of the study is to compare postoperative complications in patients undergoing major surgery who received non-filtered or filtered red blood cell transfusions.
No significant differences were found in mortality (odds ratio for filtered v non-filtered 0.80, 95% confidence interval 0.53 to 1.21) and in mean stay in intensive care (- 0.4 day, - 1.6 to 0.6 day). In the filtered group the mean length of hospital stay was 2.4 days shorter (- 4.8 to 0.0 day; P = 0.050) and the incidence of multi-organ failure was 30% lower (odds ratio 0.70, 0.49 to 1.00; P = 0.050).
There were no differences in rates of infection (0.98, 0.73 to 1.32).
Conclusion:
The use of filtered transfusions in some types of major surgery may reduce the length of hospital stay and the incidence of postoperative multi-organ failure.
- Main changes (audit trail)
- RECORD12-sep-2005 - 20-mei-2008


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