WP 8

RCT comparing personalised treatment algorithm against existing strategies for correction of

TIC

WP lead Dr Tina Gaarder, Oslo

 

Objectives

Partner 4 will lead the consortium in the set-up and conduct of a prospective, exploratory randomized control trial comparing the effect of patient-matched haemostatic resuscitation, using VHA treatment algorithmversus local empiric treatment. Specific objectives here are to:

  • Assess the potential clinical efficacy in correction of TIC upon outcomes.
  • Define potential resource use, costs and cost-effectiveness of adopting VHA-led therapy.
  • Assess the performance of risk stratification model in identifying coagulopathic patients and preventing unnecessary transfusion.
  • Provide data for the external validation of TACTIC study outputs.

 

 

Tasks

  1. Development of study protocol.
  2. With Partner 5 as sponsor, the RCT will be conducted by Partners 1-5 and the John Radcliffe Hospital, Oxford, UK as third party beneficiary to Partner 1 and coordinated by Partner 5.
  3. Prospective enrolment of trauma patients.
  4. Data capture, analysis & reporting.
  5. Health economic analysis.

 

Deliverables

Delivery date (month)

Delivered
D8.1 Clinical trial protocol: Finalised RCT protocol submitted by trial sites in application for local and National regulatory approval

24

D8.2 Clinical trial registration ID: RCT to be registered on the EU clinical trials register

24

D8.3 Final clinical trial report: Report verified by all sites prior to generation of the clinical trial report and publication according to the CONSORT 2010 Statement

57

D8.4 Final economic report.  Report detailing cost-effectiveness of implementing a personalised treatment algorithm for the management of bleeding trauma patients in EC countries

57

D8.5 Status report on resulting publications: Report updating on status of resulting publications from the RCT

60

 

 

Milestones

Delivery date (month) Delivered
MS28 All approvals in place for Randomised Control Trial 24

 

 

European Commission
Blod og væv Region Hovedstaden
Home
Intern
The TACTIC project is co-funded by the European Commission under the HEALTH-Contract No. F3-2013-602771
 

Section of Transfusion Medicine Capital Region Blood Bank & Department of Clinical Immunology
Blegdamsvej 9
2100 København Ø

CVR: 29765774
E-mail:
contact@tacticgroup.dk