NCT Number: NCT02593877
This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.
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Notify Me16 year and older
All sexes
Interventional
Phase 2
Copenhagen University Hospital, Copenhagen, Denmark
Trauma is the most frequent cause of death in persons aged under 40, with half of these deaths resulting from uncontrolled bleeding. 1 in 4 of all severely injured and shocked patients develop a clotting abnormality termed Trauma Induced Coagulopathy (TIC) within minutes of injury, which causes blood to continue being lost from the body faster than it can be stemmed. Many more injured patients will go on to develop different types of coagulopathy at different times during the course of their treatment, either as a result of their body's ongoing response to trauma or as a consequence of their clinical care. Ultimately coagulopathic patients have increased blood transfusion requirements and suffer more adverse outcomes (e.g. multi organ failure).
Current management of coagulopathic, haemorrhaging trauma patients comprises the unguided transfusion of large volumes of red blood cells and clotting product supplements. Without rapidly available and validated diagnostics, products are delivered empirically to patients blind to the type and severity of TIC they may have or indeed even if they do not have TIC. This study will compare outcomes of viscoelastic haemostatic assay (VHA)-guided resuscitation versus conventional management of critically bleeding trauma patients. The hypothesis is that goal-directed haemostatic resuscitation of coagulopathic bleeding trauma patients will yield improved outcomes and reduced blood product demand, compared to empiric massive transfusion therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult trauma patients (according to local definitions) will be enrolled if they:
Exclusion criteria
Analysis of more than 2,200 trauma subjects has enabled the definition of clinically-relevant VHA thresholds (i.e. ROTEM® and TEG® parameters) and patterns by which it is possible to rapidly identify coagulopathic patients and anticipate the need for massive transfusion. These threshold parameters have been defined and applied to the generation of an evidence-based targeted treatment algorithm (i.e. the Intervention)
Time frame: 24 hours
Proportion of subjects at 24 hours post-admission who are alive and free of massive transfusion (i.e. received 10 or more units of red blood cells within 24 hours)
Time frame: 6 hours
All-cause mortality at 6-hours post admission
Time frame: 24 hours
All-cause mortality at 24-hours post admission
Time frame: 28-days
All-cause mortality at 28-days post admission
Time frame: 90-days
All-cause mortality at 90-days post admission
Time frame: 28-days post admission
The time spent in coagulopathic state, as defined by Prothrombin Time / International Ratio (PTr) PTr >1.2) from Admission until the point of hemostasis (itself defined as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved).
Time frame: 28-days post admission
Defined by the area under the Prothrombin Time / International Ratio (PTr) curve from Admission to the point of haemostasis (where time of hemostasis is defined as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved).
Time frame: 28-days post admission
Proportion of patients with corrected coagulopathy after first 8U RBC
Time frame: 28-days post admission
Time from Admission to the point of hemostasis (where time of hemostasis is defined as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved).
Time frame: 28-days post admission
Time of haemostasis is defined the period from Admission to the point as having occurred at the end of the first hour free of red cell transfusions and the treating clinicians believe primary hemostasis has been achieved. Coagulopathy defined as PTr >1.2.
Time frame: 6 hours
Total blood products (RBC, plasma, platelets alone and in total) transfused in first 6hours after admission
Time frame: 24 hours
Total blood products (RBC, plasma, platelets alone and in total) transfused in first 24hours after admission
Time frame: 28 days
Calculated by the subtracting the number of days spent on mechanical ventilation from 28.
Time frame: 28 days
Calculated by the subtracting the number of days spent on intensive care unit from 28.
Time frame: 28 days
Length of stay will be recorded in days, for the total number spent in ICU and in Hospital. If the patient is in the hospital at any time point during a day, this day will be considered a hospital day.
Time frame: 28 days
Symptomatic venous thromboembolic events shall be recorded, as confirmed by radiology. Other thromboembolic events such as myocardial infarction and/or stroke shall be identified by standard clinical diagnostic investigation(s).
Time frame: 28-days
Incidence, category and severity of acute transfusion reactions will be defined according to UK SHOT (United Kingdom Serious Hazards of Transfusion)
Time frame: 28-days
Organ dysfunction shall be measured as Sequential Organ Failure Assessment (SOFA) score from admission to day 28 or discharge
Time frame: 28 days
Health-Related Quality of Life (HRQoL) will be measured at 28 day post admission or upon discharge if sooner
Time frame: 90 days
Health-Related Quality of Life (HRQoL) will be measured at 90 day post admission
Queen Mary University of London
Other
A Multi-centre, Prospective, Randomized Controlled Study to Compare Outcomes of Viscoelastic Haemostatic Assay (VHA)-Guided Resuscitation Versus Conventional Resuscitation Support in Haemorrhaging Trauma Patients
Acronym: iTACTIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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