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
Scientific
Sanquin Blood Supply Foundation
P.O. Box 2184
Leiden
2310 CD
Netherlands
| Phone | +31 (0)71 5685060 |
|---|---|
| Joost.vanhilten@bloodrtd.nl |
Study information
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 23/03/2000 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Sanquin Blood Supply Foundation
Leiden
2310 CD
Netherlands
2310 CD
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
