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The TACTIC project is co-funded by the European Commission under the HEALTH-Contract No. F3-2013-602771​

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

64

√​

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

64

√​

D8.5

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

66

√​

Milestones​

Delivery date (month)​

Delivered​

​MS28

All approvals in place for Randomised Control Trial

24

√​

Section of Transfusion Medicine Capital Region Blood Bank & Department of Clinical Immunology

Blegdamsvej 9
DK-2100 København Ø

CVR: 29765774

E-mail: contact@tacticgroup.dk