Dallas 2015 TFQO: Jan Jensen COI #115 EVREVs: Jan Jensen COI #115 Richard N. Bradley COI #151 Taskforce: First Aid 769: Hemostatic Dressings

Dallas 2015 COI Disclosure (specific to this systematic review) Commercial/industry Jensen – None Bradley – None Potential intellectual conflicts Jensen – None Bradley Resuscitation Sub-council Chairman, American Red Cross Scientific Advisory Council Board member, Citizen CPR Foundation

Dallas CoSTR Consensus on Science Evidence from 4 LOE 4 studies in adults showed a significant improvement compared with standard treatment for out-of-hospital control of life-threatening bleeding when topical hemostatic agents were used by trained individuals. This beneficial outcome was supported by 21 LOE 5 animal studies. Effectiveness varied substantially among the agents used. Adverse effects of some agents included tissue destruction with induction of a proembolic state and potential thermal injury. Treatment Recommendation The out-of-hospital application of a topical hemostatic agent to control life-threatening bleeding not controlled by standard techniques is reasonable, but the best agent and the conditions under which it should be applied are not known.

Dallas 2015 C2015 PICO Population: patients with severe external bleeding Intervention: the application of topical hemostatic dressings plus standard first aid Comparison: standard first aid alone Outcomes: overall mortality, vital signs, hemostasis, complications, blood loss, major bleeding, incidence of cardiac arrest

Dallas 2015 Inclusion/Exclusion & Articles Found Inclusion criteria: Humans or animals Hemostatic dressings (not granules) External bleeding Exclusion criteria: Not primary research Bleeding not external Bleeding not severe Hemostatic dressing not used or used in combination with other things 1,250 Number of Articles Finally Evaluated

Dallas Proposed Treatment Recommendations We suggest (weak) hemostatic dressings* be used when standard first aid hemorrhage control cannot control bleeding by first aid providers; very low quality of evidence. Values and preferences statement: In making this recommendation, we place increased value on the benefits of hemostasis, which outweigh the risks. The cost of the intervention is moderate. *This PICO specifically addressed hemostatic dressings and does not apply to other agents (such as granules) that may be applied alone or followed by a plain dressing.

Dallas 2015 Risk of Bias: RCT Studies (all animal) StudyYearDesign Total nPopulation Industry Funding Allocation: Generation Allocation: Concealment Blinding: Participants Blinding: Assessors Outcome: Complete Outcome: Selective Other Bias Acheson2005 RCT (animal)45 swine - femoral artery hemorrhageUNCLEAR unclea rhigh low Alam2003 RCT (animal)60 swine - extremity hemorrhageNO unclea r high lowhighunclear Arnaud2009 (632) RCT (animal)16 swine - groin hemorrhageYEShigh low Arnaud2009 (848) RCT (animal)16 swine - groin hemorrhageYEShigh lowhighlow Causey2012 RCT (animal)17 swine - femoral artery hemorrhageUNCLEARhigh lowhighlow Devlin2011 RCT (animal)24 swine - groin hemorrhageYEShigh lowhighlow Kheirabadi2009 RCT (animal)16 swine - femoral artery hemorrhageYEShigh lowhighlow Kozen2008 RCT (animal)24 swine - groin hemorrhageYEShigh lowhighlow

Dallas 2015 Risk of Bias: non-RCT Studies (human) StudyYearDesign Total PatientsPopulation Industry Funding Eligibility Criteria Exposure/ Outcome Confounding Follow-Up Brown2009 retrospective case series34 EMS patients - severe external bleedingunclearhigh low Cox2009 retrospective case series18 Military - severe external bleedingnohigh Ran2010 retrospective case series14 Military - severe external bleedingunclearhigh low Wedmore2006 retrospective case series64 Military - severe external bleedingnohigh low

Dallas 2015 Evidence profile table(s)

Dallas 2015 Evidence profile table(s)

Dallas 2015 Evidence profile table(s)

Dallas 2015 Proposed Consensus on Science statements For the critical outcome of “overall mortality”, we have identified very low quality evidence from one human case series showing benefit, where 21% (1/26) of patients receiving hemostatic dressings died. We also identified very low quality evidence from seven animal studies showing benefit, where 40.7% (25/86) of patients who received hemostatic dressings died, compared to 65.8% (54/82) who did not receive hemostatic dressings (RR 0.62 (0.46 – 0.83)).

Dallas 2015 Proposed Consensus on Science statements For the critical outcome of “hemostasis”, very low quality evidence from four human case series enrolling 130 participants showing benefit where hemostasis occurred in 90.8% of participants (no comparison group). We also identified very low quality evidence from three animal studies showing benefit where hemostasis occurred in 74.2% (23/31), compared to 50% (13/26) (RR 1.48 (0.96 – 2.30)).

Dallas 2015 Proposed Consensus on Science statements For the critical outcome of “complications”, very low quality evidence from four human case series studies enrolling 96 participants showing benefit that complications from hemostatic dressing occur in 3% (3/96) of participants (no comparison group). For the important outcome of “time to bleeding cessation”, very low quality evidence from one human case series showing benefit that 73% (25/34) of participants achieved hemostasis in under three minutes with a hemostatic dressing applied (no comparison group).

Dallas 2015 Draft Treatment Recommendations We suggest (weak) hemostatic dressings* be used when standard first aid hemorrhage control cannot control bleeding by first aid providers; very low quality of evidence. Values and preferences statement: In making this recommendation, we place increased value on the benefits of hemostasis, which outweigh the risks. The cost of the intervention is moderate. *This PICO specifically addressed hemostatic dressings and does not apply to other agents (such as granules) that may be applied alone or followed by a plain dressing.

Dallas 2015 Knowledge Gaps How much training is required and what type of training should be used for first aid providers to apply hemostatic dressings to bleeding wounds Which specific hemostatic dressings should be used by first aid providers? In humans, how do hemostatic dressings compare to properly applied standard first aid providers?

Dallas 2015 Next Steps Consideration of interim statement Person responsible Due date