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Randomized Controlled Trials: Informing Clinical Practice for Traumatically Injured Patients

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Trauma Induced Coagulopathy

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Abstract

Well-designed randomized controlled trials have changed trauma resuscitation dramatically over the past few decades. Randomized controlled trials have established the effectiveness of permissive hypotension and the use of balanced blood product resuscitation to minimize mortality in traumatically injured patients. Together, these therapeutic concepts are termed “damage control resuscitation” and are now the standard of care for traumatically injured patients at risk of hemorrhagic shock and therefore trauma-induced coagulopathy.

In order to inform and change clinical practice, experimental human trials require special consideration. Each trial must be created with the safety of participants in mind. The clinical research team is responsible for establishing a trial design and statistical analysis plan which tests a question or hypothesis with scientific value and validity. To respect the trial participants and inform clinical practice, all trial planning, analysis, and outcomes must be reported appropriately both prior to data collection and at the completion of the trial. Therefore, only trials that are carefully and ethically designed, implemented, and analyzed which are adequately and transparently reported should be used to modify norms of clinical practice.

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Abbreviations

COMBAT:

Control of Major Bleeding After Trauma

CRASH:

Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage

DSMB:

Data and Safety Monitoring Boards

IRB:

Institutional Review Boards

PAMPer:

Prehospital Air Medical Plasma

PROMMTT:

PRospective, Observational, Multicenter, Major Trauma Transfusion

PROPPR:

Pragmatic, Randomized Optimal Platelet and Plasma Ratios

RCT:

Randomized controlled trial

STAAMP:

Study of Tranexamic Acid during Air Medical Prehospital

TXA:

Tranexamic acid

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Suggested Reading

  • Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. Br Med J. 1996;313(7057):570–1.

    Article  CAS  Google Scholar 

  • Anderson ML, Chiswell K, Peterson ED, Tasneem A, Toppings J, Califf R. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372(11).

  • Bickell W, Wall M, Pepe P, Martin R, Ginger V, Allen M, et al. Immediate versus delayed fluid resuscitation for hypotensive patients with penetrating torso injuries. N Engl J Med. 1994;331(17):1105–9.

    Article  CAS  Google Scholar 

  • CRASH Trial Collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with signifi cant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet [Internet]. 2010;376 https://doi.org/10.1016/S0140-6736(10)60835-5.

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    Article  Google Scholar 

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    Article  CAS  Google Scholar 

  • Moore HB, Moore EE, Chapman MP, McVaney K, Bryskiewicz G, Blechar R, et al. Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial. Lancet [Internet]. 2018 [Cited 2019 Jun 3];392(10144):283–91.

    Google Scholar 

  • Sperry J, Guyette F, Brown J, Yazer M, Triulzi D, Early-Young B, et al. Prehospital plasma during air medical transport in trauma patients at risk for hemorrhagic shock. N Engl J Med. 2018;376(4):315–26.

    Article  Google Scholar 

  • U.S. Department of Health and Human Services, Food and Drug Administration, Office of Good Clinical Practice. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: exception from informed consent requirements for emergency research [Internet]. Vol. 2. 2013.

    Google Scholar 

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Author information

Authors and Affiliations

  1. Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA

    Katherine M. Reitz & Jason L. Sperry

  2. Center for Clinical Trials and Data Coordination, University of Pittsburgh, Pittsburgh, PA, USA

    Andrew D. Althouse

Authors
  1. Katherine M. Reitz
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  2. Andrew D. Althouse
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  3. Jason L. Sperry
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Corresponding author

Correspondence to Jason L. Sperry .

Editor information

Editors and Affiliations

  1. Department of Surgery, University of Colorado, Aurora, CO, USA

    Hunter B. Moore

  2. Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA

    Matthew D. Neal

  3. Department of Surgery, University of Colorado Denver, Ernest E Moore Shock TraumaCenter at Denver Health, Denver, CO, USA

    Ernest E. Moore

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Reitz, K.M., Althouse, A.D., Sperry, J.L. (2021). Randomized Controlled Trials: Informing Clinical Practice for Traumatically Injured Patients. In: Moore, H.B., Neal, M.D., Moore, E.E. (eds) Trauma Induced Coagulopathy. Springer, Cham. https://doi.org/10.1007/978-3-030-53606-0_40

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  • DOI: https://doi.org/10.1007/978-3-030-53606-0_40

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  • Online ISBN: 978-3-030-53606-0

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