Transfusion induced complications = transfusion associated complications? study

ISRCTN	ISRCTN48093674
DOI	https://doi.org/10.1186/ISRCTN48093674
Protocol serial number	n/a
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Sanquin Bloodbank Amsterdam (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	The effects of leukocyte filtered versus buffy coat depleted erythocyte transfusions in major surgery patients
Study acronym	TACTICS
Study objectives	Does 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) studied	Blood transfusions complications
Intervention	Transfusions of filtered red blood cell concentrates versus transfusion of stored buffy coat depleted red blood cell concentrates.
Intervention type	Other
Primary outcome measure(s)	Postoperative: 1. In-hospital mortality 2. Duration of intensive care stay
Key secondary outcome measure(s)	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 Follow up : 1. Long term survival 2. Cancer recurrence in GI patients 3. Predictive role of cytokines and related genes
Completion date	31/12/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1548
Key inclusion criteria	Acute aneurysm-, elective aneurysm-, orthopaedic- and large gastro-intestinal surgery patients.
Key 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
Date of first enrolment	23/03/2000
Date of final enrolment	31/12/2001

Sanquin Blood Supply Foundation

Leiden
2310 CD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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