Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

  1. 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.

Additional files

Editorial Notes