Transfusion induced complications = transfusion associated complications? study

ISRCTN ISRCTN48093674
DOI https://doi.org/10.1186/ISRCTN48093674
Secondary identifying numbers n/a
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
04/12/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.A. Hilten, van
Scientific

Sanquin Blood Supply Foundation
P.O. Box 2184
Leiden
2310 CD
Netherlands

Phone +31 (0)71 5685060
Email Joost.vanhilten@bloodrtd.nl

Study information

Study designMulticentre, randomised, double blinded, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effects of leukocyte filtered versus buffy coat depleted erythocyte transfusions in major surgery patients
Study acronymTACTICS
Study objectivesDoes removal of allogeneic white blood cells by filtration reduce postoperative complications?
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedBlood transfusions complications
InterventionTransfusions of filtered red blood cell concentrates versus transfusion of stored buffy coat depleted red blood cell concentrates.
Intervention typeOther
Primary outcome measurePostoperative:
1. In-hospital mortality
2. Duration of intensive care stay
Secondary outcome measures1. 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
Overall study start date23/03/2000
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants1548
Key inclusion criteriaAcute aneurysm-, elective aneurysm-, orthopaedic- and large gastro-intestinal surgery patients.
Key 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
Date of first enrolment23/03/2000
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Sanquin Blood Supply Foundation
Leiden
2310 CD
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Sanquin Bloodbank Amsterdam (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 29/05/2004 Yes No