Contact information
Type
Scientific
Primary contact
Dr J.A. Hilten, van
ORCID ID
Contact details
Sanquin Blood Supply Foundation
P.O. Box 2184
Leiden
2310 CD
Netherlands
+31 (0)71 5685060
Joost.vanhilten@bloodrtd.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
n/a
Study information
Scientific title
The effects of leukocyte filtered versus buffy coat depleted erythocyte transfusions in major surgery patients
Acronym
TACTICS
Study hypothesis
Does removal of allogeneic white blood cells by filtration reduce postoperative complications?
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, double blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Postoperative:
1. In-hospital mortality
2. Duration of intensive care stay
Secondary outcome measures
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
Overall trial start date
23/03/2000
Overall trial end date
31/12/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Acute aneurysm-, elective aneurysm-, orthopaedic- and large gastro-intestinal surgery patients.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1548
Participant 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
Recruitment start date
23/03/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
Netherlands
Trial participating centre
Sanquin Blood Supply Foundation
Leiden
2310 CD
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanquin Bloodbank Amsterdam (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15142885
Publication citations
-
Results
van Hilten JA, van de Watering LM, van Bockel JH, van de Velde CJ, Kievit J, Brand R, van den Hout WB, Geelkerken RH, Roumen RM, Wesselink RM, Koopman-van Gemert AW, Koning J, Brand A, Effects of transfusion with red cells filtered to remove leucocytes: randomised controlled trial in patients undergoing major surgery., BMJ, 2004, 328, 7451, 1281, doi: 10.1136/bmj.38103.735266.55.