Prediction of Massive Transfusion in Trauma Patients

NCT04561050 | Completed

• 1 other identifier: MTPSSTR20152019
• Study Type: observational
• Target: 13,222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trauma Injury; Haemorrhagic Shock; Bleeding; Emergencies; Blood Transfusion; Massive Hemorrhage; Massive Transfusion; Adult; Bleeding Hemorrhage; Hemorrhage / Mortality; Cohort Study; Female; Male; Hospital Mortality; Humans; Models, Theoretical; Prognosis; Wounds and Injuries / Mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Death due to bleeding

  at 28 days after trauma

• Early death (< 24 hours)

  24 hours after trauma

• Coagulopathy at Hospital admission

  within 2 hours of hospital admission

Interventions

Comparison of score performances (Overall performance, discrimination and calibration) OTHER

Our Study is an observational non-interventional study based on a multicentric anonymized registry. It's an external validation of pre-existing prognostic scores of traumatic haemorrhages 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 statistic intervention will be a comparison of score performances (Overall performance, discrimination and calibration).

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will use data from the Swiss Trauma Registry (STR) , which represents the Swiss trauma system, serving the country's 8.6 million inhabitants. The STR collect data on patients with major trauma who have been admitted to a level I Swiss trauma centre (Centre Hospitalier Universitaire Vaudois, Hôpitaux universitaire Genevois, Inselspital Bern, Universitätsspital Basel, Universitätsspital Zürich, Kantonsspital St. Gallen, Luzerner Kantonsspital, Kantonsspital Aarau, Kantonsspital Graubünden, Kantonsspital Winterthur, EOC - Ospedale Regionale di Lugano, Gesundheitsnetwerk Wallis - Standort Sion). Major trauma has been defined according to the inclusion criteria of the STR.

You may qualify if:

• Age \> 16 years old
• ISS ≥ 16 and/or AIS head ≥ 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (9)

• Yucel 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. doi: 10.1097/01.ta.0000220386.84012.bf.

  PMID: 16766965 BACKGROUND

• Maegele M, Lefering R, Wafaisade A, Theodorou P, Wutzler S, Fischer P, Bouillon B, Paffrath T; Trauma Registry of Deutsche Gesellschaft fur 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.

  PMID: 20735809 BACKGROUND

• 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.

  PMID: 19204506 BACKGROUND

• 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.

  PMID: 20622617 BACKGROUND

• 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.

  PMID: 31142526 BACKGROUND

• 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.

  PMID: 20553376 BACKGROUND

• 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, Negrier 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.

  PMID: 21112053 BACKGROUND

• Brohi K, Cohen MJ, Davenport RA. Acute coagulopathy of trauma: mechanism, identification and effect. Curr Opin Crit Care. 2007 Dec;13(6):680-5. doi: 10.1097/MCC.0b013e3282f1e78f.

  PMID: 17975390 BACKGROUND

• Costa A, Carron PN, Zingg T, Roberts I, Ageron FX; Swiss Trauma Registry. Early identification of bleeding in trauma patients: external validation of traumatic bleeding scores in the Swiss Trauma Registry. Crit Care. 2022 Sep 28;26(1):296. doi: 10.1186/s13054-022-04178-8.

  PMID: 36171598 DERIVED

Related Links

• Swiss Trauma Registry, official Website

MeSH Terms

Conditions

Accidental Injuries; Shock, Hemorrhagic; Hemorrhage; Emergencies; Wounds and Injuries

Interventions

Calibration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Doctor François-Xavier Ageron, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY DIRECTOR

• Pierre-Nicolas Carron, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 23, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: August 29, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)