|- candidate number||1507|
|- NTR Number||NTR309|
|- ISRCTN||ISRCTN48093674 |
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Transfusion induced complications = transfusion associated complications ? study.|
|- Scientific Title||The effects of leukocyte filtered versus buffy coat depleted erythocyte transfusions in major surgery patients.|
|- hypothesis||Does removal of allogeneic white blood cells by filtration reduce postoperative complications?|
|- Healt Condition(s) or Problem(s) studied||Complications, Blood transfusions|
|- Inclusion criteria||Acute aneurysm-, elective aneurysm-, orthopaedic- and large gastro-intestinal surgery patients.|
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-mrt-2000|
|- planned closingdate||31-dec-2001|
|- Target number of participants||1548|
|- Interventions||Transfusions of filtered red blood cell concentrates vs. transfusion of stored buffy coat depleted red blood cell concentrates.|
|- Primary outcome||Postoperative:|
1. In-hospital mortality;
2. Duration of intensive care stay.
|- Secondary outcome||1. 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;
1. Long term survival;
2. Cancer recurrence in GI patients;
3. Predictive role of cytokines and related genes.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.A. Hilten, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.A. Hilten, van|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Bloodbank Amsterdam|
|- Publications||1. BMJ 2004; 328:1281-4|
2. Ned Tijdschrift voor Hematologie 2005;
|- Brief summary||The 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).
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)|
|- RECORD||12-sep-2005 - 20-mei-2008|