Control of severe, life-threatening external bleeding in the out-of-hospital setting: Pressure dressings, bandages, devices or proximal pressure (FA): Systematic Review

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 declared

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 declared

CoSTR Citation

Charlton NP, Swain JM, Nieuwlaat R, Singletary EM, Zideman DA, Epstein JL, Bendall JC, Berry DC, Borra V, Carlson JN, Cassan P, Chang WT, Hood N, Markenson DS, Meyran D, Woodin JA, Sakamoto T, Lang E: Control of severe external bleeding in the out-of-hospital setting: Pressure dressings, bandages, devices, or proximal pressure 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, and with involvement of ILCOR First Aid Task Force clinical content experts. Evidence from adult and pediatric literature was sought and considered by the First Aid Task Force. Additional scientific literature published after 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 the clinical content experts judged as performed in sufficiently similar conditions to still be 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 on Control of Severe, Life-threatening Bleeding in the Out-of-Hospital Setting. This CoSTR specifically addresses use of pressure dressings, bandages, devices, or proximal pressure compared with direct manual 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 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

Pressure dressings/bandages/devices compared with direct manual pressure

For the critical outcome of time to hemostasis, no direct evidence was found from the prehospital setting, however, we identified very low certainty evidence (downgraded for very serious indirectness and serious imprecision) from three RCTs{Chlan 2005 391; Lehmann 1999 1118; Walker 2001 366} in the in-hospital setting with a total of 918 patients undergoing endovascular procedures. Due to heterogeneity, these studies could not be combined for meta-analysis, however, none of the studies showed benefit with the use of pressure dressings/bandages/devices compared with manual compression, with an overall longer time to hemostasis with the use of pressure dressings/bandages/devices compared with manual compression. In one study{Lehmann 1999 1118} the mean time to hemostasis with the use of a pneumatic device was 15.6± 4.8 minutes compared with a mean time of 14.5 ± 4.5 minutes with the use of a clamp and 13.9 ± 3.5 minutes in the manual compression group (overall p = 0.006). In another study{Walker 2001 366} the mean time to hemostasis in the femoral compression system (Femostop^Ò) device group was 35.2 ± 12.3 minutes compared with the manual compression time of 12.9 ± 12.4 minutes (p < 0.001). In the third study{Chlan 2005 391}, mean time to hemostasis by device was as follows: femoral compression system (FemoStop^Ò) 40.2 ± 23.2, C-clamp 32.6 ± 9.8 and manual 27.5 ± 6.3 minutes (p < 0.0001).

We identified very low certainty evidence (downgraded for serious risk of bias, indirectness, and imprecision) from two cohort studies{Semler 1985 234; Sulzbach-Hoke 2010 E1} in the in-hospital setting with a total 3,528 patients undergoing endovascular procedures. These studies showed varying results with use of pressure dressings/bandages/devices compared with manual compression. The first study{Sulzbach-Hoke 2010 E1} with 273 patients found no benefit with the use of a C-clamp compared with manual compression as patients with a C-clamp had a higher median compression time to achieve hemostasis than subjects who received direct manual compression (median [min-max]: 35 min [10-110] compared with 20 min [10-45]; p < 0.001). The second study{Semler 1985 234} with 3,255 patients showed a benefit for pressure dressings/bandages/devices where the use of a mechanical clamp had a time to hemostasis of 19.9 minutes compared with 33.5 minutes for those receiving direct manual pressure (p value not reported).

For the critical outcome of cessation of bleeding, we identified very low certainty evidence (downgraded for very serious indirectness and serious imprecision) from one RCT{Lehmann 1999 1118} in the in-hospital setting with 400 patients undergoing endovascular procedures. This study failed to show a benefit for the use of pressure dressings/bandages/devices in that 73% of patients in the pneumatic compression device group achieved hemostasis, while 99% of patients in each of the clamp compression and the manual compression groups achieved hemostasis (overall p < 0.0001).

We identified very low certainty evidence (downgraded for serious risk of bias, indirectness, and imprecision) from one cohort study{Boulanger 2014 102} in the in-hospital setting among 64 patients with arterio-venous fistula puncture for hemodialysis. This study showed benefit with the use of pressure dressings/bandages/devices bandage compared with manual compression as bleeding cessation was achieved in 47% and 44% when manual compression was used in the study (first and third weeks of the block study design), whereas bleeding cessation was achieved in 82% of patients with use of an elasticized compression bandage (IRIS^Ò) in the second week of the study (p < 0.05).

For the important outcome of complications/adverse effects, we identified very low certainty evidence (downgraded for very serious indirectness and serious imprecision) from three RCTs{Chlan 2005 391; Lehmann 1999 1118; Walker 2001 366} in the in-hospital setting with a total of 918 patients undergoing endovascular procedures. Due to heterogeneity these studies could not be combined for meta-analysis. One study{Walker 2001 366} showed a higher rate of complications in the pressure device/bandages group (21/116 [18.1%]) compared with the manual pressure group (13/143 [9.0%]) RR, 1.99; 95% CI, 1.04-3.80; p = 0.04)]. Another study{Lehmann 1999 1118} showed no difference in complications with the use of a device (26.1% [64/245] compared with the manual pressure group (25.0% [38/152]) (RR, 1.05; 95% CI, 0.74-1.48; p = 0.80)]. A third study{Chlan 2005 391} showed fewer complications in the pressure dressing/device group (94/207 [45.4%]) compared with the manual pressure group (56/99 [56.6%]) (RR, 0.80; 95% CI, 0.64-1.01; p = 0.06)].

We identified very low certainty evidence (downgraded for serious risk of bias, indirectness, and imprecision) from three observational studies{Boulanger 2014 102; Semler 1985 234; Sulzbach-Hoke 2010 E1} in the in-hospital setting with a total of 3,790 patients either undergoing an arterio-venous fistula puncture for hemodialysis or undergoing endovascular procedures. One cohort study{Semler 1985 234} showed benefit with the use of pressure dressings/bandages/devices compared with manual compression with a lower a rate of complications in the pressure dressings/bandages/devices group compared with the manual pressure group (2.0% compared with 6.0%; p < 0.001). A second cohort study{Sulzbach-Hoke 2010 E1} in patients undergoing percutaneous coronary intervention showed a comparable rate of complications with the use of the C-clamp compared (40/223 [17.9%]) compared with manual compression (19/105 [18.1%]); (p value not calculated). The third study{Boulanger 2014 102} reported no complications using the IRIS® bandage or manual compression in patients with an arterio-venous fistula puncture.

We did not find evidence for the critical outcome of death due to bleeding, or the important outcome of death from any cause.

Pressure points compared with direct manual pressure

We did not identify any human studies comparing pressure points with direct manual pressure for the management of severe, life-threatening external bleeding, however, three simulation studies were found to help experts formulate treatment recommendations.

Treatment Recommendations

We recommend that first aid providers use direct manual compression compared with the use of external compression devises or pressure dressings/bandages for severe life-threatening external bleeding (strong recommendation, very low certainty of evidence).

We recommend against the use of pressure points compared with the use of direct pressure by first aid providers for severe, life-threatening external bleeding (strong recommendation, very low certainty of evidence).

Justification and Evidence to Decision Framework Highlights

• In making a strong recommendation, we considered direct manual pressure as the fundamental first step in the initial management of any life-threatening external bleeding

• The Task Force was strongly influenced by 3 RCT’s {Chlan 2005 391; Lehmann 1999 1118; Walker 2001 366} in which the use of manual compression achieved a shorter average time to hemostasis than the use of pressure dressings/bandages/devices in patients undergoing endovascular procedures.

• We considered that direct manual pressure is available to all first aid providers, has no cost and can be provided equitably in all jurisdictions. The use of pressure dressings or devices may increase treatment cost and, therefore, health care disparity. In addition they may need specialized training for use.

• The Task Force acknowledges that improved education is likely to be needed to enhance the quality of direct manual pressure for the cessation of life-threatening external bleeding. It is felt that this training should be incorporated into all standard first aid training and would not take additional resources to do so. The Task Force acknowledges that the study results are mixed and indirect and that when applied appropriately, external compression devices/bandages may be equally efficacious.
• We also considered the low certainty of evidence surrounding the use of pressure points for life-threatening bleeding and placed considerable value in the fact that that there is no direct human evidence that the use of pressure points is effective in the treatment of life-threatening external bleeding.
• While there is some evidence that lay providers are able to use pressure points and that pressure points may halt some forms of bleeding it is the opinion of the Task Force that this evidence is not sufficient to validate the use of pressure points in life-threatening external bleeding.
• The Task Force recognised the lack of pre-hospital data. It also recognised that the use of in-hospital data derived from endovascular puncture and arterio-venous puncture may not be applicable to pre-hospital life threatening bleeding. It further acknowledged that in many of these in-hospital environments that subjects were often given anticoagulants that may or may not have been reversed, thereby further complicating the assessment of cessation of bleeding.
• 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:

• Experimental or observational studies comparing pressure dressings/bandages/devices with direct manual pressure in patients with severe, life-threatening external bleeding in the out-of-hospital setting
• There is currently a lack of studies comparing direct manual pressure to pressure devices/bandages in the presence of severe or life-threatening external bleeding in the first aid setting.
• Optimal methods to provide direct manual pressure
• Optimal methods to teach proper application of direct manual pressure
• Does provider fatigue play a role with treating life-threatening external bleeding with direct manual pressure?
• Experimental or observational studies comparing pressure points with direct manual pressure in patients with severe, life-threatening external bleeding in the out-of-hospital setting
• Is there a role for the use of pressure points for adjunctive therapy for life-threatening external bleeding?
• Can first aid providers appropriately locate pressure points?
• Are pressure dressings or pressure points useful in the paediatric population?

Attachments

Evidence-to-Decision table: Pressure dressings vs direct pressure

Evidence-to-Decision table: Pressure points vs direct pressure

References

Boulanger H, Ahriz-Saksi S, Flamant M, Vigeral P. Evaluation of post-puncture bleeding time of arteriovenous fistulas with IRIS® bandage. J Vasc Access. 2014 Mar-Apr;15(2):102-7. doi: 10.5301/jva.5000176. Epub 2013 Oct 31.

Chlan LL, Sabo J, Savik K. Effects of three groin compression methods on patient discomfort, distress, and vascular complications following a percutaneous coronary intervention procedure. Nurs Res. 2005 Nov-Dec;54(6):391-8.

Lehmann KG, Heath-Lange SJ, Ferris ST. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J. 1999 Dec;138(6 Pt 1):1118-25.

Semler HJ. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology. 1985 Jan;154(1):234-5.

Sulzbach-Hoke LM, Ratcliffe SJ, Kimmel SE, Kolansky DM, Polomano R. Predictors of complications following sheath removal with percutaneous coronary intervention. J Cardiovasc Nurs. 2010 May-Jun;25(3):E1-8. doi: 10.1097/JCN.0b013e3181c83f4b.

Walker SB, Cleary S, Higgins M. Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications following coronary angioplasty and coronary stent placement. Int J Nurs Pract. 2001 Dec;7(6):366-75.