TOP-TBI
Research type
Research Study
Full title
Timing Of venous thromboembolism Prophylaxis for adult patients with Traumatic Brain Injury (TOP-TBl): a pragmatic, randomised trial
IRAS ID
1009812
Contact name
Angelos Kolias
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
ISRCTN Number
ISRCTN64696029
Research summary
Patients who have suffered a Traumatic Brain Injury (TBI) due to falls, assaults, road traffic accidents etc are at risk of developing blood clots in the veins (VTE) and this will complicate their recovery from TBI , could lead to long-term reduction in quality of life and occasionally can be fatal. Doctors typically give TBI patients blood thinning medication to reduce the chances of developing VTE but some doctors worry that these drugs could increase the risk of further bleeding in the brain if given too soon following the injury. Several studies have shown that giving blood thinning medication within 72 hours of injury does nor increase the risk of further bleeding compared to giving the medication later than 120 hours or not giving it at all if deemed clinically unnecessary. This study aims to recruit 1512 patients with TBI and compare the timing of giving blood thinning medication (within 72 hours vs more than 120 hours following TBI or not at all) and to guide the best practice in the future for initiating the drugs in order to reduce the risk of blood clots without introducing complications from further bleeding.
For this trial patients, following informed consent and eligibility screening, will be randomly allocated (by a computer) into one of two groups. the "early" group will start blood thinning medication within 72 hours of injury while the "late" group will have their medication deferred by at least 120 hours from injury or not given at all. Patients will be given the medications while they are in hospital. The aim of the study is to ascertain the optimal timing of VTE prophylaxis in TBI patients by comparing the two groups in terms of development of VTE within 30 and 90 days from trial enrolment, mortality at 7 and 30 days and 12 months and quality of life following discharge from hospital. Patients will be asked about their quality of life at 30 days and then at 6 and 12 months via postal questionnaire, email or phone call.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0202
Date of REC Opinion
3 Dec 2024
REC opinion
Further Information Favourable Opinion