Control of severe, life-threatening external bleeding in the out-of-hospital setting: Hemostatic devices (FA): Systematic Review

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This Review is a draft version prepared by ILCOR, with the purpose to allow the public to comment and is labeled “Draft for Public Comment". The comments will be considered by ILCOR. The next version will be labelled “draft" to comply with copyright rules of journals. The final Review will be published on this website once a summary article has been published in a scientific Journal and labeled as “final”.

Conflict of Interest Declaration

The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: none applicable

The following Task Force members and other authors declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees: none applicable

CoSTR Citation

Charlton NP, Swain JM, Nieuwlaat R, Singletary EM, Zideman DA, Epstein JL, Bendall JC, Berry DC, Carlson JN, Cassan P, Chang WT, Hood NA, Markenson DS, Meyran D, Woodin JA, Sakamoto T, Lang E, on behalf of the International Liaison Committee on Resuscitation First Aid Task Force. Control of severe, life-threatening external bleeding in the out-of-hospital setting: Hemostatic devices Consensus on Science with Treatment Recommendations [Internet] Brussels, Belgium: International Liaison Committee on Resuscitation (ILCOR) First Aid Task Force, 2019 December 20. Available from: http://ilcor.org

Methodological Preamble and Link to Published Systematic Review

The continuous evidence evaluation process for the production of the Consensus on Science with Treatment Recommendations (CoSTR) started with a systematic review of control of severe external bleeding in the out-of-hospital setting (22 March 2018, PROSPERO CRD42018091326) conducted by Evidence Prime, an international Knowledge Synthesis Unit with members from the UK, Poland and Canada with involvement of ILCOR First Aid clinical content experts. Evidence from adult and pediatric literature was sought and considered by the First Aid Task Force. Additional scientific literature published after the completion of the systematic review was identified by the content experts and incorporated into the CoSTR. These data were taken into account when formulating the Treatment Recommendations.

We included all studies from the out-of-hospital setting (direct evidence), as well as studies providing indirect evidence about the effects of interventions collected in combat (military) settings, simulations (i.e. human volunteers, human cadaver or other models excluding animal models), and studies performed in the hospital setting, that clinical content experts judged as were performed in sufficiently similar conditions to still be both relative and informative. Bleeding from compressible and non-compressible external sites were included, except for epistaxis. No literature was identified specific to the pediatric population, and a sub-group analysis for children compared with adults was not possible.

This CoSTR is one of four CoSTRs related to the systematic review completed simultaneously on Control of Severe Bleeding in the Out-of-Hospital Setting. This CoSTR specifically addresses use of hemostatic devices compared with direct pressure. The other CoSTRs will be published separately on ILCOR.org/costr.

Systematic Review

Nathan P. Charlton, Janel M. Swain, Jan L. Brozek, Maja Ludwikowska, Eunice Singletary, David Zideman, Jonathan Epstein, Andrea Darzi, Anna Bak, Samer Karam, Zbigniew Les, Jestin N Carlson, Eddy Lang, Robby Nieuwlaat & On behalf of the International Liaison Committee on Resuscitation (ILCOR) First Aid Task Force (2020) Control of severe, life-threatening external bleeding in the out-of-hospital setting: a systematic review, Prehospital Emergency Care, DOI: 10.1080/10903127.2020.1743801

PICOST

The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)

Population: Adults and children with severe, life-threatening external bleeding in out-of-hospital settings. Bleeding from both compressible and non-compressible external sites were included.

Intervention: All bleeding control methods applicable for use by trained or untrained first aid providers including manufactured or improvised tourniquets, hemostatic dressings or agents, cryotherapy, direct (manual) pressure, pressure points, pressure dressings or bandages or elevation of the injured area. Manufactured tourniquets included windlass-style or elastic, with single or double application.

Comparators: Studies with comparators of bleeding control methods are included, as well as observational cohorts with a single bleeding control technique which in an observational meta-analysis may allow comparison of one technique against another.

Outcomes:

  • Mortality due to life-threatening bleeding (Critical)
  • Cessation of bleeding / achieving hemostasis (Critical)
  • Time to achieving hemostasis (Critical)
  • Mortality from any cause (Important)
  • Decrease in bleeding (Important)
  • Complications/adverse effects (e.g. wound infection, limb loss, re-bleeding, pain related to an intervention) (Important)

Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies) were eligible for inclusion.

Timeframe: All years and all languages were included as long as there was an English abstract; unpublished studies (e.g., conference abstracts, trial protocols) were excluded. Literature search updated to November 22, 2019.

PROSPERO Registration: CRD42018091326

Consensus on Science

Junctional tourniquets compared with direct pressure

We did not identify any human studies comparing junctional tourniquets with direct pressure for the management of severe, life-threatening external bleeding, however, 12 simulation studies were reviewed to help formulate treatment recommendations.

Wound clamps compared with direct pressure

We did not identify any human studies comparing wound clamps with direct pressure for the management of severe, life-threatening external bleeding, however, two case series were reviewed to help formulate treatment recommendations.

Treatment Recommendations

Due to the lack of comparative evidence, we are unable to recommend for or against the use a junctional tourniquet by first aid providers in comparison with direct manual pressure alone for severe, life-threatening external bleeding.

Due to the lack of comparative evidence, we are unable to recommend for or against the use of wound clamps by first aid providers in the out-of-hospital setting in comparison with other hemostatic techniques for severe, life-threatening external bleeding.

Justification and Evidence to Decision Framework Highlights

  • No high certainty evidence was found to compare the use of junction tourniquets or wound clamps to direct pressure. Twelve simulation studies and two case series were reviewed by the task force to help formulate treatment recommendations.
  • In considering the evidence, the Task Force recognizes that data regarding the use of junctional tourniquets by first aid providers comes primarily from simulation studies and without comparators to direct pressure. While these studies generally show favourable results, the Task Force has concerns about the ability of first aid providers to learn to properly apply junctional tourniquets in a real prehospital setting. No evidence was identified that assessed the efficacy or adverse effects of direct (manual) pressure in comparison with either the use of junctional tourniquets or the C-clamp. In addition, the use of direct manual pressure by first aid providers is a traditional ‘gold standard’ technique for control of bleeding that in most situations can be quickly applied and with minimal training. For these reasons, we are unable to recommend for, or against use of junctional tourniquets by first aid providers
  • The Task Force recognizes that benefits of junctional tourniquets may justify their use in specific populations (e.g. military organizations) that require hands-free control of life-threatening bleeding from wounds in locations not amenable to alternative methods for the control of bleeding.
  • In considering the data for wound clamps, only a two case series of 10 patients {McKee 2018 39; Tan 2016 1012} from the prehospital setting were identified. While outcomes in this study were positive, the indirectness of these case series with application of an invasive medical device by health care professionals rather than by lay people raises the concern that we do not know if this is a skill that can be used by or taught to first aid providers. In addition, regulatory restrictions may prohibit use of these devices by unlicensed care providers.
  • The Task Force recognizes that wound clamps represent a significant cost, and therefore, may increase health care disparity.
  • The Task Force also places significant value on the perceived risks of placing a wound clamp by lay providers over the limited data on benefit. For these reasons, we are unable to recommend for, or against use of wound clamps by first aid providers.
  • No identified comparative studies included specific data on children, precluding subgroup analysis. However, in task force discussions it was felt that in the absence of specific evidence for the Pediatric population that it would be reasonable for guideline groups to apply recommendations for control of life-threatening bleeding to children.

Knowledge Gaps

Current knowledge gaps include but are not limited to:

  • There are no experimental or observational studies comparing use of junctional tourniquets with use of direct manual pressure in patients with severe, life-threatening bleeding in the out-of-hospital setting.
  • Are first aid providers able to recognize wounds that would be amenable to junctional tourniquets?
  • Are first aid providers able to appropriately apply junctional tourniquets?
  • Is one type of junctional pressure device superior to another type of junctional tourniquets in the first aid setting?
  • There are no experimental or observational studies comparing the use of wound clamps with the use of direct pressure in patients with severe, life-threatening bleeding in the out-of-hospital setting.
  • There are no studies evaluating the use of junctional tourniquets or wound clamps in the pediatric population.

Attachments

Evidence-to-Decision Table: Wound clamps vs. other hemostatic techniques

Evidence-to-Decision Table: Junctional pressure device vs. direct pressure

References

Chen J, Benov A, Nadler R, et al. Testing of Junctional Tourniquets by Medics of the Israeli Defense Force in Control of Simulated Groin Hemorrhage. J Spec Oper Med. 2016 Spring;16(1):36-42.

Cotte J, Cungi PJ, Montcriol A. Experimental evaluation of the Combat Ready Clamp. J Trauma Acute Care Surg. 2013 Oct;75(4):747-8. doi: 10.1097/TA.0b013e31829cbf48.

Gaspary MJ, Zarow GJ, Barry MJ, Walchak AC, Conley SP, Roszko PJD. Comparison of Three Junctional Tourniquets Using a Randomized Trial Design. Prehosp Emerg Care. 2018 Aug 17:1-8. doi: 10.1080/10903127.2018.1484968.

Gates KS, Baer L, Holcomb JB. Prehospital emergency care: evaluation of the junctional emergency tourniquet tool with a perfused cadaver model. J Spec Oper Med. 2014 Spring;14(1):40-4.

Kragh JF Jr, Aden JK 3rd, Lambert CD, Moore VK 3rd, Dubick MA. Assessment of User, Glove, and Device Effects on Performance of Tourniquet Use in Simulated First Aid. J Spec Oper Med. Winter 2017;17(4):29-36.

Kragh JF, Kotwal RS, Cap AP, et al. Performance of Junctional Tourniquets in Normal Human Volunteers. Prehosp Emerg Care. 2015 Jul-Sep;19(3):391-8. doi: 10.3109/10903127.2014.980478. Epub 2014 Dec 12.

Kragh JF, Lunati MP, Kharod CU, et al. Assessment of Groin Application of Junctional Tourniquets in a Manikin Model. Prehosp Disaster Med. 2016 Aug;31(4):358-63. doi: 10.1017/S1049023X16000443. Epub 2016 May 27.

Kragh JF Jr, Mann-Salinas EA, Kotwal RS, et al. Laboratory assessment of out-of-hospital interventions to control junctional bleeding from the groin in a manikin model. Am J Emerg Med. 2013 Aug;31(8):1276-8. doi: 10.1016/j.ajem.2013.03.021. Epub 2013 Jul 1.

Kragh JF Jr, Parsons DL, Kotwal RS, et al. Testing of junctional tourniquets by military medics to control simulated groin hemorrhage. J Spec Oper Med. 2014 Fall;14(3):58-63.

Lyon M, Johnson D, Gordon R. Use of a Novel Abdominal Aortic and Junctional Tourniquet to Reduce or Eliminate Flow in the Brachial and Popliteal Arteries in Human Subjects. Prehosp Emerg Care. 2015 Jul-Sep;19(3):405-8. doi: 10.3109/10903127.2014.980479. Epub 2014 Dec 12.

McKee JL, Kirkpatrick AW, Bennett BL, Jenkins DA, Logsetty S, Holcomb JB. Worldwide Case Reports Using the iTClamp for External Hemorrhage Control. J Spec Oper Med Peer Rev J SOF Med Prof. 2018 Fall;18(3):39–44.

Meusnier JG, Dewar C, Mavrovi E, Caremil F, Wey PF, Martinez JY. Evaluation of Two Junctional Tourniquets Used on the Battlefield: Combat Ready Clamp® versus SAM® Junctional Tourniquet. J Spec Oper Med. 2016 fall;16(3):41-46.

Tan EC, Peters JH, Mckee JL, Edwards MJ. The iTClamp in the management of prehospital haemorrhage. Injury. 2016 May;47(5):1012-5. doi: 10.1016/j.injury.2015.12.017. Epub 2015 Dec 29.

Taylor DM, Coleman M, Parker PJ. The evaluation of an abdominal aortic tourniquet for the control of pelvic and lower limb hemorrhage. Mil Med. 2013 Nov;178(11):1196-201. doi: 10.7205/MILMED-D-13-00223.

Theodoridis CA, Kafka KE, Perez AM, et al. Evaluation and Testing of Junctional Tourniquets by Special Operation Forces Personnel: A Comparison of the Combat Ready Clamp and the Junctional Emergency Treatment Tool. J Spec Oper Med. 2016 Spring;16(1):44-50


Tourniquets, Clamps

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