Dallas 2015 TFQO: Jan Jensen COI #115 EVREV: Michael Reilly COI #193 Taskforce: First Aid First Aid 768: Use of Tourniquet

Dallas 2015 COI Disclosure Jan Jensen COI #115 Commercial/industry No conflicts Potential intellectual conflicts No conflicts Michael Reilly COI #193 Commercial/industry No conflicts Potential intellectual conflicts No conflicts

Dallas Treatment Recommendation Properly applied tourniquets do control hemorrhage under surgical and battlefield conditions, but because of potential complications, there are insufficient data for or against recommending their routine use in civilian first aid. In civilian settings, tourniquets should only be used for control of extremity hemorrhage if direct pressure is not adequate or possible (e.g., multiple injuries, inaccessible wounds, multiple victims). Specifically designed tourniquets are superior to improvised ones but should only be used with proper training. There is insufficient evidence to determine how long a tourniquet can remain in place safely. Cooling of the distal limb should be considered if a tourniquet needs to remain in place for a prolonged period of time.

Dallas 2015 C2015 PICO Population:adults and children with external limb bleeding Intervention:application of a tourniquet Comparison:not applying a tourniquet Outcomes: hemostasis (9 – critical), overall mortality (9 – critical), vital signs (8 – critical), functional limb recovery (7 – critical), complications (7 – critical), blood loss (6 – important), incidence of cardiac arrest (5 – important)

Dallas 2015 Inclusion/Exclusion & Articles Found Inclusions: Humans (indirect) with severe external bleeding or volunteers Tourniquet applied Exclusions: Surgical studies, opinion articles, animal Number of Articles initially identified: 994 Number Included: 12 RCTs: 0 non-RCTs: 12

Dallas Proposed Treatment Recommendations We suggest (weak) properly-applied tourniquet be used when standard first aid hemorrhage control (including direct pressure) cannot control bleeding by first aid providers; low quality of evidence. Values & preferences: Difference in vital signs clinically insignificant Not a significant difference found in mortality

Dallas 2015 Risk of Bias in studies StudyYearDesign Total PatientsPopulation Industry Funding Eligibility Criteria Exposure/ Outcome Confounding Follow-Up Guo2011 observational study: prospective comparison200volunteerslow unclearlow Wall2012 observational study: prospective comparison150volunteersunclearlow unclearlow Swan2009 observational study: prospective comparison130volunteersunclearlow unclearlow Kragh2014 observational study: retrospective comparison1413war settinglow Passos2014 observational study: retrospective comparison190civilian EMS, adultslow unclearlow Beekley2008 observational study: retrospective comparison165war settingunclearlow unclearhigh Kragh2011 observational study: retrospective case series499war settingunclearlow highunclear Lakstein2002 observational study: retrospective case series91war settingunclearlow highlow Kragh2012 observational study: retrospective case series88 pediatrics in war settingunclearlowhigh low King2012 observational study: retrospective case series79war settingunclearlowhigh low Brodie2007/2009 observational study: retrospective case series70war settingunclearlow highlow Tien2008 observational study: retrospective case series6war settinglowhigh low

Dallas 2015 Types of Tourniquet Studied TypeStudies CATBrodie, King, Kragh 2012 Stretch, Wrap And Tuck (SWAT)Wall BladderGuo WindlassGuo Cargo-strapGuo Rubber tubeGuo ImprovisedGuo, Lakstein, Passos UnknownBeekley, Kragh 2011, Tien, Kragh 2014

Dallas 2015 Key data from key studies Kragh 2014 P: US war causalities with major trauma I: tourniquet applied C: no tourniquet applied O: survival

Dallas 2015 Evidence profile table

Dallas 2015 Evidence profile table

Dallas 2015 Evidence profile table

Dallas 2015 Evidence profile table

Dallas 2015 Proposed Consensus on Science For the critical outcome of hemostasis, we have identified: low quality evidence from: one human study with a comparison group (evidence downgraded for risk of bias & indirectness) enrolling 70 patients, showing benefit where 83% (35/42) of those who had a tourniquet applied achieved hemostasis compared to 61% (17/28) of those who did not have a tourniquet applied (RR (6.55 – 16.96)) (Beekley 2008, s28) very low quality evidence five human case series (evidence downgraded for risk of bias and indirectness) enrolling 480 patients, showing benefit where 72% (473/655) patients who had tourniquet applied achieved hemostasis (Guo 2011, 151; Lakstein 2002, s221; King 2012, 33; Swan 2009, 672; Wall 2012, 1366), evidence downgraded for risk of bias and indirectness.

Dallas 2015 Proposed Consensus on Science For the critical outcome of “mortality”, we identified: low quality evidence from three human studies with a comparison group enrolling 1768 patients showing no difference where 12% (91/791) of patients who had a tourniquet applied died compared to 9% (89/977) of patients who did not have a tourniquet applied (RR 1.08 (0.82 – 1.43)) (Beekley 2008, s28; Passos 2014, 573; Kragh 2014, s0196) very low quality evidence six human case series studies (evidence downgraded for risk of bias) enrolling 808 patients, where 10% (82/808) of those patients who had tourniquet applied died (Brodie 2007, 74; King 2012, 33; Kragh 2011, 590; Kragh 2012, 1362; Lakstein 2002, s221; Tien 2008, 174).

Dallas 2015 Proposed Consensus on Science statements For the critical outcome of “vital signs”, we identified: low quality evidence low quality evidence from three human studies with a comparison group enrolling 1642 participants demonstrates no benefit with a mean difference in heart rate of 3 beats per minute more (0.21 – 6.91) if tourniquet applied (Beekley 2008, s28; Passos 2014, 573; Kragh 2014, s0196) (Evidence downgraded due to risk of bias). Low quality evidence from two human studies with a comparison group enrolling 284 participants demonstrates no benefit and mean difference in systolic blood pressure of 9 mmHg less ( ) if tourniquet applied (Beekley 2008, s28; Passos 2014, 573) (evidence downgraded due to risk of bias and imprecision).

Dallas 2015 Proposed Consensus on Science statements For the critical outcome of “complications”, we identified: low quality evidence from one human study with a comparison group enrolling 165 patients (evidence downgraded due to risk of bias and imprecision), showing benefit where 6% (6/67) patients who had tourniquet applied had complications compared to 9% (9/98) who did not have tourniquet applied had complications (RR 0.19 (0.06 – 0.55)) (Beekley 2008, s28) very low quality evidence three human case series studies enrolling 751 patients shows complications from tourniquets occur in 4% (34/751) (Brodie 2007, 74; Kragh 2011, 590; Lakstein 2002, s221)

Dallas 2015 Draft Treatment Recommendations We suggest (weak) tourniquet be used when standard first aid hemorrhage control cannot control bleeding by first aid providers; low quality of evidence. Values and Preferences: In making this recommendation, we place increased value on the benefits of hemostasis, which outweigh the risks. The cost of the intervention is moderate.

Dallas 2015 Knowledge Gaps Specific research required: Tourniquet vs no tourniquet: controlled trial Civilian setting Adults and children Control for confounders, such as concurrent use of hemostatics Major external bleeding: prospective registry study Rare event in civilian EMS/FA Comparison between types of tourniquets, including between commercial tourniquets, injury severity, provider types, time to surgery, etc. Training required for FA providers, and requirement for refresher If instructions can safely be given by EMS dispatchers

Dallas 2015 Next Steps This slide will be completed during Task Force Discussion (not EvRev) and should include: Consideration of interim statement Person responsible Due date Essential slide (one slide only). Estimated time <30 sec