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iTACTIC - implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a
Kjersti Baksaas-Aasen1, Lewis Gall2, Simon Eaglestone2
1Department of Traumatology, Oslo University Hospital, Oslo, Norway.
Trials
|October 20, 2017
Summary
This study compares Viscoelastic Haemostatic Assays (VHAs) to conventional coagulation tests (CCTs) for managing bleeding trauma patients. It aims to determine if VHA-guided therapy improves outcomes compared to CCT-guided therapy in reducing massive transfusions and mortality.
Area of Science:
- Trauma and Emergency Medicine
- Hematology and Coagulation
- Clinical Trials and Study Design
Background:
- Traumatic injury is a leading global cause of death, with hemorrhage accounting for half of all trauma fatalities.
- Early trauma-induced coagulopathy (TIC) can worsen bleeding and increase mortality, yet current transfusion strategies often fail to correct it.
- While Viscoelastic Haemostatic Assays (VHAs) are increasingly used, evidence for their superiority over conventional coagulation tests (CCTs) in managing trauma hemorrhage is limited.
Purpose of the Study:
- To compare the efficacy of VHA-guided versus CCT-guided transfusion algorithms in adult trauma patients experiencing hemorrhagic shock.
- To evaluate patient-centered outcomes, including mortality, organ failure, and resource utilization, between the two guided transfusion strategies.
- To address the existing knowledge gap regarding the optimal management of bleeding trauma and the role of VHAs.
Main Methods:
- A multicenter, randomized controlled trial involving 392 adult trauma patients with signs of hemorrhagic shock and massive transfusion protocols activated.
- Patients were randomized to receive either VHA-guided or CCT-guided transfusion therapy in addition to standard care until hemostasis was achieved.
- Primary endpoint: proportion of subjects alive and free of massive transfusion (less than 10 units of RBCs) at 24 hours. Secondary outcomes include organ failure, length of stay, and mortality.
Main Results:
- The study is designed to provide data on the primary endpoint of alive and free of massive transfusion at 24 hours.
- Secondary outcomes will assess the impact of VHA-guided versus CCT-guided therapy on organ failure, hospital and ICU length of stay, and mortality.
- Quality of life will be assessed using the EuroQol EQ-5D questionnaire at 90 days for surviving patients.
Conclusions:
- Conventional coagulation tests (CCTs) have been the standard for managing traumatic hemorrhage, but their effectiveness in correcting trauma-induced coagulopathy (TIC) is debated.
- The increasing use of VHAs necessitates rigorous evaluation to confirm their superiority for patient-centered outcomes in trauma hemorrhage.
- This trial aims to provide critical evidence to guide transfusion strategies in bleeding trauma patients, potentially optimizing patient care and outcomes.
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