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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Klinikum der Universität Köln | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VHA algorithm | Experimental | Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC 1: plasma 1: platelets 1) and VHA-guiding further resuscitation with blood products and procoagulant factors |
|
| Control | No Intervention | Massive transfusion protocol resuscitation aiming at ratio 1:1:1 of blood components (RBC 1: plasma 1: platelets 1) and conventional coagulation tests guiding further resuscitation with blood products and procoagulant factors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VHA algorithm | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects alive and free of massive transfusion | 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) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 6hr Mortality | All-cause mortality at 6-hours post admission | 6 hours |
| 24hr Mortality | All-cause mortality at 24-hours post admission |
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Inclusion Criteria:
Adult trauma patients (according to local definitions) will be enrolled if they:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim Brohi, FCRS FRCA | Queen Mary University of London, Barts Health NHS Trust | Study Director |
| Christine Gaarder, MD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Copenhagen | Denmark | ||||
| Kliniken der Stadt Köln gGmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29047413 | Derived | Baksaas-Aasen K, Gall L, Eaglestone S, Rourke C, Juffermans NP, Goslings JC, Naess PA, van Dieren S, Ostrowski SR, Stensballe J, Maegele M, Stanworth SJ, Gaarder C, Brohi K, Johansson PI. iTACTIC - implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial. Trials. 2017 Oct 18;18(1):486. doi: 10.1186/s13063-017-2224-9. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D020141 | Hemostatic Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Rigshospitalet, Denmark |
| OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| Barts & The London NHS Trust | OTHER |
| European Commission | OTHER |
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|
| 24 hours |
| 28d Mortality | All-cause mortality at 28-days post admission | 28-days |
| 90d Mortality | All-cause mortality at 90-days post admission | 90-days |
| Duration of coagulopathy | 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). | 28-days post admission |
| Severity of coagulopathy | 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). | 28-days post admission |
| Proportion of patients with corrected coagulopathy after first 8U RBC | Proportion of patients with corrected coagulopathy after first 8U RBC | 28-days post admission |
| Time to hemostasis | 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). | 28-days post admission |
| Time spent in coagulopathic condition until haemostasis | 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. | 28-days post admission |
| 6hr Blood products transfused | Total blood products (RBC, plasma, platelets alone and in total) transfused in first 6hours after admission | 6 hours |
| 24hr Blood products transfused | Total blood products (RBC, plasma, platelets alone and in total) transfused in first 24hours after admission | 24 hours |
| 28d Ventilator-free days | Calculated by the subtracting the number of days spent on mechanical ventilation from 28. | 28 days |
| 28d ICU-free days | Calculated by the subtracting the number of days spent on intensive care unit from 28. | 28 days |
| Length of stay | 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. | 28 days |
| Symptomatic thromboembolic events | 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). | 28 days |
| Transfusion-related complications | Incidence, category and severity of acute transfusion reactions will be defined according to UK SHOT (United Kingdom Serious Hazards of Transfusion) | 28-days |
| Organ dysfunction | Organ dysfunction shall be measured as Sequential Organ Failure Assessment (SOFA) score from admission to day 28 or discharge | 28-days |
| 28d/discharge QoL | Health-Related Quality of Life (HRQoL) will be measured at 28 day post admission or upon discharge if sooner | 28 days |
| 90d QoL | Health-Related Quality of Life (HRQoL) will be measured at 90 day post admission | 90 days |
| Cologne |
| Germany |
| Academic Medical Centre | Amsterdam | Netherlands |
| Oslo University Hospital | Oslo | Norway |
| The Royal London Hospital | London | Greater London | E1 1BB | United Kingdom |
| Queens Medical Centre | Nottingham | United Kingdom |
| John Radcliffe Hospital | Oxford | United Kingdom |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |