Bleeding Clinical Trial
— MTPOfficial title:
Prediction of Massive Transfusion in Trauma Patients in Prehospital and In-hospital: Data From Swiss Trauma Registry (STR)
Verified date | March 2022 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Since the 2000s, many prognostic scores were developed to predict traumatic haemorrhage. Most of these studies were retrospectives based on registers. Due to missing data on death due to bleeding, these studies chose to predict the massive transfusion risk as a surrogate of haemorrhagic death. These scores include clinical parameters (vital signs), laboratory values (Haemoglobin, lactate, Base excess) and/or imaging (CT or ultrasound) values. The scores showing best performance are the Trauma Associated Severe Haemorrhage (TASH) score, developed and validated on the German register (DGU-Register) and the ABC score developed and validated in the United States of America. However, the majority of these scores cannot be applied at the trauma scene due to the unavailability of laboratory and imaging values. Therefore, their clinical utility remains unclear. To overcome the need for diagnostic tests, authors have developed and recently validated a clinical prognostic score in identifying trauma patients with, or at risk of, significant haemorrhage based on predicted probabilities of death due to bleeding: BATT score. This score was developed from an international cohort using data from 271 Trauma Centres in 41 countries on 5 continents and uses first clinical parameters at initial assessment. The BATT score predicts death due to bleeding and has been validated on a large population in England and Wales. It could also predict massive transfusion, as a surrogate of haemorrhagic death, earlier at the trauma scene. Its feasibility and external validation would make its clinical utility superior to other scores while identifying a greater number of patients requiring early management. Our study is an external validation of pre-existing prognostic scores of traumatic haemorrhages (TASH , ABC and BATT score) at different times of care (Scene of Injury, admission at the trauma room) in order to assess their overall performance, discrimination and calibration in the prediction of massive transfusion, and haemorrhagic death. The objective of the study is to assess a comparison of score performances (Overall performance, discrimination and calibration). Due to the study population (STR), which is partly integrated into the German DGU-Register, the investigators expect good transportability of the TASH score to the Swiss Trauma Registry in terms of overall performance, discrimination and calibration. The ABC score should show lowers results in terms of discrimination due to its validation on small cohorts exclusively in North America. The new BATT score predicting death due to bleeding has been validated on a large English cohort of more than 100,000 patients. It identifies all patients with haemorrhage and not only patients who have received a massive transfusion subject to survival bias. In this context, the BATT score provides good discrimination with only simple physiological variables available at the trauma scene. In case of its external validation on the STR as part of our study, its feasibility would make its clinical utility superior to other pre-existing scores, while identifying a greater number of patients requiring early management. Its application would activate a massive transfusion plan directly at the trauma scene and save precious time.
Status | Completed |
Enrollment | 13222 |
Est. completion date | August 29, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | All trauma patients included in the Swiss Trauma Registry (STR) between 01.01.2015 and 31.12.2019 have been recorded according to these inclusion criteria of the STR: Inclusion Criteria: - Age > 16 years old - ISS = 16 and/or AIS head = 3 Exclusion Criteria: - Age < 16 years old - ISS < 16 and/or AIS head <3 - Isolated Burns (including electric shock) or if the burn is clearly the primary injury - Patients arriving at the trauma room without signs of life and no diagnostic/therapeutic measures have been initiated for them - Choking or Hanging patient without any other injury - Drowning patients |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois |
Switzerland,
Ageron FX, Gayet-Ageron A, Steyerberg E, Bouzat P, Roberts I. Prognostic model for traumatic death due to bleeding: cross-sectional international study. BMJ Open. 2019 May 28;9(5):e026823. doi: 10.1136/bmjopen-2018-026823. — View Citation
Brohi K, Cohen MJ, Davenport RA. Acute coagulopathy of trauma: mechanism, identification and effect. Curr Opin Crit Care. 2007 Dec;13(6):680-5. Review. — View Citation
Cotton BA, Dossett LA, Haut ER, Shafi S, Nunez TC, Au BK, Zaydfudim V, Johnston M, Arbogast P, Young PP. Multicenter validation of a simplified score to predict massive transfusion in trauma. J Trauma. 2010 Jul;69 Suppl 1:S33-9. doi: 10.1097/TA.0b013e3181e42411. — View Citation
Floccard B, Rugeri L, Faure A, Saint Denis M, Boyle EM, Peguet O, Levrat A, Guillaume C, Marcotte G, Vulliez A, Hautin E, David JS, Négrier C, Allaouchiche B. Early coagulopathy in trauma patients: an on-scene and hospital admission study. Injury. 2012 Jan;43(1):26-32. doi: 10.1016/j.injury.2010.11.003. Epub 2010 Nov 26. — View Citation
Frith D, Goslings JC, Gaarder C, Maegele M, Cohen MJ, Allard S, Johansson PI, Stanworth S, Thiemermann C, Brohi K. Definition and drivers of acute traumatic coagulopathy: clinical and experimental investigations. J Thromb Haemost. 2010 Sep;8(9):1919-25. doi: 10.1111/j.1538-7836.2010.03945.x. — View Citation
Maegele M, Lefering R, Wafaisade A, Theodorou P, Wutzler S, Fischer P, Bouillon B, Paffrath T; Trauma Registry of Deutsche Gesellschaft für Unfallchirurgie (TR-DGU). Revalidation and update of the TASH-Score: a scoring system to predict the probability for massive transfusion as a surrogate for life-threatening haemorrhage after severe injury. Vox Sang. 2011 Feb;100(2):231-8. doi: 10.1111/j.1423-0410.2010.01387.x. Epub 2010 Aug 24. — View Citation
Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: simple as ABC (assessment of blood consumption)? J Trauma. 2009 Feb;66(2):346-52. doi: 10.1097/TA.0b013e3181961c35. — View Citation
Yücel N, Lefering R, Maegele M, Vorweg M, Tjardes T, Ruchholtz S, Neugebauer EA, Wappler F, Bouillon B, Rixen D; Polytrauma Study Group of the German Trauma Society. Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma. J Trauma. 2006 Jun;60(6):1228-36; discussion 1236-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of Massive transfusion | The primary outcome is the presence of massive transfusion (MT) in Swiss trauma patients, defined by a transfusion equal to or greater than 10 Red blood cell (RBC) in the first 24 hours or = 3 RBC in the first hour if available in the Swiss Trauma Registry. | 24 hours after trauma | |
Secondary | Death due to bleeding | Secondary outcome is death due to bleeding if available in the registry (will be used for sensibility analysis) | at 28 days after trauma | |
Secondary | Early death (< 24 hours) | early death: Death in the first 24 hours (will be used for sensibility analysis) | 24 hours after trauma | |
Secondary | Coagulopathy at Hospital admission | Coagulopathy is defined by an INR > 1.2 or TP < 70% or Fibrinogen = 1.5 g/L (will be used for sensibility analysis) | within 2 hours of hospital admission |
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