Professional Documents
Culture Documents
To cite this article: Eileen M. Bulger, David Snyder, Karen Schoelles, Cathy Gotschall, Drew
Dawson, Eddy Lang, Nels D. Sanddal, Frank K. Butler, Mary Fallat, Peter Taillac, Lynn White,
Jeffrey P. Salomone, William Seifarth, Michael J. Betzner, Jay Johannigman & Norman McSwain
Jr. (2014) An Evidence-based Prehospital Guideline for External Hemorrhage Control: American
College of Surgeons Committee on Trauma, Prehospital Emergency Care, 18:2, 163-173, DOI:
10.3109/10903127.2014.896962
ABSTRACT
163
164 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
The use of tourniquets and hemostatic agents in the Representatives were from both the United States and
civilian EMS community is not widespread.4,5 While Canada. Panelists provided input to the formulations
there is increasing interest in the use of these agents of the PICOTS (populations, interventions, compara-
by civilian EMS agencies, the differences between the tors, outcomes, timing, and settings) questions prior to
civilian and military populations may be important. the initiation of the literature review. For the PICOTS
These considerations, not well addressed in the pub- questions, the population of interest was defined
lished military experience, include the use of these to be individuals with extremity hemorrhages; the
modalities in elderly and pediatric patients and the interventions were commercially available tourniquets
impact of medical comorbidities on outcome. Even as and hemostatic dressings; comparators were external
recently as 2011, the Guidelines for Field Triage of In- wound pressure and nontourniquet or nonhemostatic
jured Patients does not include a recommendation for interventions; outcomes of interest were limb salvage,
tourniquet use as a trauma triage criteria because “ev- hypovolemic shock, survival, and adverse effects.
idence is limited regarding the use of tourniquets in Because timing and setting were considered to be
civilian populations; use of tourniquets among EMS key aspects of the investigation the PICO format was
systems varies; inclusion of tourniquet use as a cri- expanded to include both immediate and long-term
terion could lead to overuse of tourniquets instead outcomes and the setting for the intervention was
of basic hemorrhage control methods, and thus defined as the prehospital environment, before any
potentially result in overtriage.”6 However, the Na- procedures are performed in the hospital emergency
tional EMS Scope of Practice Model published in 2007 department or operating theater. Following the com-
lists tourniquet use as part of the minimum psy- pletion of the systematic literature review, the panel
chomotor skill set for emergency trauma care for emer- met to review the literature in a full day meeting
gency medical technicians. In addition, tourniquets in Washington DC, October 2013. An expert in the
have been included as required basic life support (BLS) application of the GRADE methodology facilitated the
equipment in the Joint Policy Statement: Equipment meeting and the panel used this approach to develop
for Ambulances.7 Topical hemostatic agents are listed recommendations for each PICOTS question.
as optional basic equipment. The recent Hartford con-
sensus conference also encourages wider civilian use
of tourniquets for management of hemorrhage in ac-
Evidence Review
tive shooter events.8 A systematic review of the literature was conducted
The purpose of this project was to develop evidence- by the ECRI Institute, one of the eleven Evidenced-
based guidelines for the use of tourniquets and Based Practice Centers designated by the U.S. Agency
hemostatic dressings in the U.S. civilian prehospi- for Healthcare Research and Quality. Their system-
tal setting. The recommendations were based on a atic literature review and evidence tables were used
systematic review of the current literature and were by the expert panel to develop these recommenda-
developed using the GRADE methodology.9 External tions. A summary of the findings is included in this
hemorrhage is defined as blood loss originating from manuscript; the full ECRI report will be simulta-
a ruptured blood vessel and appearing on the body neously published by the National Highway Traffic
surface. For the purposes of our review, this includes Safety Administration (NHTSA) and will be available
extremity hemorrhage and junctional hemorrhage. at www.ems.gov. The PICOTS questions used to guide
Junctional hemorrhage includes the groin proximal the literature review were developed with input from
to the inguinal ligament, the buttocks, the gluteal and the multidisciplinary expert panel.
pelvic areas, the perineum, the axilla and shoulder Literature search included 13 external and inter-
girdle, and the base of the neck.10 nal electronic databases, including CINAHL, EM-
BASE, and Medline, from 2001 to the present
for fully published, primary, clinical studies. The
APPROACH Cochrane Database of Systematic Reviews (Cochrane
Reviews), Database of Abstracts of Reviews of Ef-
Expert Panel
fects (DARE), and Health Technology Assessment and
An expert panel was convened by the American Database (HTA) were also searched for secondary
College of Surgeons Committee on Trauma EMS reviews. Additional search steps included manual
Committee to include nationally recognized experts search of bibliographies listed in fully published stud-
in prehospital trauma care. Representatives were ies; search and written inquiry to regulatory agen-
included from the military’s Tactical Casualty Combat cies, including the U.S. Food and Drug Administra-
Care Committee, Prehospital Trauma Life Sup- tion; and search of www.ClinicalTrials.gov and www.
port, civilian State EMS directors, trauma surgeons, controlled-trials.com for ongoing clinical trials. Pub-
emergency physicians, a pediatric surgeon, an EMS lications were also suggested for inclusion by expert
researcher, a GRADE methodologist, and a paramedic. panel members who commented on the draft report.
E. M. Bulger et al. PREHOSPITAL GUIDELINE FOR EXTERNAL HEMORRHAGE CONTROL 165
The criteria for inclusion in the systematic review their effect on limb salvage, hypovolemic shock,
were studies published in English that reported on survival, and adverse effects?
traumatic hemorrhage treated by EMS personnel in 4) In trauma patients with junctional hemorrhage
the prehospital setting with tourniquets or hemostatic who are treated in the prehospital setting by EMS
dressings currently available in U.S. commercial mar- personnel, do different brands or models of spe-
kets. In addition, the studies reported findings on at cialized junctional hemorrhage control devices
least one of the outcomes identified in the PICOTS differ from each other in their effect on limb sal-
questions and included at least 5 patients per treat- vage, hypovolemic shock, survival, and adverse
ment group; results for extremity and junctional hem- effects?
orrhage were considered separately. To avoid duplica- 5) In trauma patients with external hemorrhage (ex-
tion, when several sequential reports from the same cludes junctional hemorrhage) who are treated in
study center were available, only findings from the the prehospital setting using a tourniquet –
largest, most recent, or most complete report was a) Does the incidence of adverse events vary
used. Because of the paucity of published studies on by the duration of tourniquet use prior to
hemostatic dressings, for these questions the inclusion removal?
criteria were expanded to include animal studies of b) Does the incidence of adverse events vary de-
FDA-cleared or approved hemostatic dressings using pending on whether tourniquets are removed
either a swine or goat model of extremity bleeding. in the field versus in a facility?
Risk of bias and other indicators of strength of evi- 6) In trauma patients with external hemorrhage
dence were assessed and reported. (hemorrhage from any body surface) who are
The absolute risk differences and relative risk (RR) treated in the prehospital setting, what is the ef-
with 95% confidence intervals for the primarily di- fect of hemostatic dressings with or without ex-
chotomous outcomes were calculated for individual ternal wound pressure on, control of hemorrhage,
studies. In cases in which meta-analyses was possible limb salvage (if an extremity involved), hypov-
a summary odds ratio (OR) was calculated using a olemic shock, survival, and adverse effects com-
random effects model. Studies were combined using pared with using non-hemostatic gauze with or
meta-analysis when populations and interventions without external wound pressure?
were similar. Given the nature of the populations 7) In trauma patients with external hemorrhage
examined in this report, military populations were (hemorrhage from any body surface) who are
separated from civilian populations and data from treated in the prehospital setting, do different
children (younger than 18 years of age) was also brands or types of hemostatic dressings differ
examined independently. Statistical heterogeneity was from each other in their effect on, hemorrhage
examined using I2 , but the small number of studies in control, limb salvage (if an extremity is involved),
the comparisons limited our confidence in measures hypovolemic shock, survival, and adverse ef-
of heterogeneity. fects?
study design, GRADE allows the evidence appraisal to that met our inclusion criteria (Figure 1). While not the
be upgraded or downgraded, depending on such fac- focus of this review we also reviewed 39 animal model
tors as the size and consistency of the reported effect or studies, which compared efficacy of the topical hemo-
the presence of a dose response.19 Using the GRADE static agents. Nine studies were identified that used
terminology, strong recommendations begin with the only human volunteers and these were excluded.
words “we recommend” and indicate that the panel
believes that the benefits clearly outweigh any risks Tourniquet Use
associated with the treatment and that nearly all in-
formed patients would want the recommended treat- We identified 20 publications of prehospital tourniquet
ment. Weak recommendations begin with the words use for trauma-induced extremity hemorrhage. How-
“we suggest,” which indicates that the panel had a ever, four publications did not provide information on
higher level of uncertainty about estimated benefits of outcomes needed for inclusion in this report: Lairet
the treatment the balance between benefits and risks. et al.,20 Gerhardt et al.,21 Kragh et al.,22 Kragh et al.23 In
two instances, the same study population was assessed
RESULTS in two separate publications. Kragh et al.24 and Kragh
et al.25 used the same set of 499 patients and Kragh
Summary of Evidence Review et al.26 and Kragh et al.27 used the same set of 232 pa-
Our searches identified 1,599 potential citations for tients. The 16 included publications are listed in Table 1
evaluation and full review identified 23 clinical studies along with the setting in which the data on tourniquet
Abstracts
200 Citations excluded
screened
23 clinical studies:
16 studies of tourniquets
7 clinical studies of hemostatic dressings
9 studies with human volunteers
3 simulation studies
39 Animal model studies
Eastridge et al., 20121 U.S. military Oct 2001 to 976 Not reported Deaths
Iraq/Afghanistan June 2011
King et al., 201240 U.S. military Aug 2011 to 54 Not reported Deaths, adverse events
Afghanistan Nov 2011
Kragh et al., 201228 U.S. military May 2003 to 88 (pediatric) 72 were male and 16 were female patients. Deaths
Iraq/Afghanistan Dec 2009 Mean age was 11 years (median, 11 years;
pediatric casualties range, 4–17 years). Injuries: explosion 64%,
gunshot 30%, other 6%.
Kotwal et al., 201129 U.S. military Oct 2001 to 460 All casualties were male, with age at time of Deaths, amputations
Iraq/Afghanistan March 2010 (66 w/tourniquet) injury ranging from 18.9 to 52.9 years.
Injuries: explosion 67%, gunshot 24%, blunt
trauma 6%.
Kragh et al., 201125 U.S. military March 2006 to 499 96% male, average age 29 years, 16 were Deaths, adverse events
Iraq March 2007 children and 5 elderly. Injury: explosion 75%.
Kragh et al., 201124 (same study U.S. military March 2006 to 499 96% male, average age 29 years, 16 were Adverse events
as Kragh et al., 201125 but Iraq March 2007 children and 5 elderly. Injury: explosion 75%.
reporting morbidities)
Brown et al., 201041 U.K. military Aug 2003 to 23 Median age 26 years, range 18–42 years, not Adverse events
Iraq/Afghanistan May 2008 specific to tourniquet patients. Injuries for
entire patient pool: explosion 62%, gunshot
38%.
Brodie et al., 200942 U.K. military Feb 2003 to 70 Gender and age data not reported. Injuries: Deaths, amputations,
Iraq/Afghanistan Sept 2007 explosion 86%, gunshot 14%. adverse events
Clasper et al., 200931 U.K. military Dec 2003 to 44 Tourniquet group: mean age of 26.6 years, range Amputations, adverse
Iraq/Afghanistan May 20008 (22 w/tourniquet) 19–37 years. Injuries: explosion 32%. events
Nontourniquet group: mean age of 25.7 years,
range 19–37 years. Injuries: explosion 64%.
Kragh et al., 200926 U.S. military March to Oct 232 95% male, mean age of 29 years, range Deaths, amputations,
(reassessment of data from Iraq 2006 (194 w/tourniquet) 4–70 years, 9 children and 1 elderly. Injuries: adverse events
Kragh et al., 200827 ) explosion 63%, gunshot 23%.
Tien et al., 200943 Canadian military Feb 2006 to 134?? Entire study examined 134 patients, 96% male, Deaths
Afghanistan May 2006 mean age of 26 years. Injuries: explosion 34%,
gunshot 32%, blunt 22%.
Beekley et al., 200830 U.S. military Jan 2004 to 165 (67 w/ Tourniquet group: 97% male, mean age of Deaths, amputations,
Iraq Dec 2004 tourniquet) 29 years. Injuries: explosion 64%, gunshot adverse events
30%.
Nontourniquet group: 96% male, mean age of
25. Injuries: explosion 70%, gunshot 27%.
Dayan et al., 200832 Israeli military 2006 5 (prolonged All males, 20–22 years old. Injuries: explosion = Deaths, amputations,
tourniquet use) 1, gunshot. = 4. adverse events
Kalish et al., 200844 U.S. civilian Jan 1999 to 11 All males, mean age of 27 years, gunshot Deaths and adverse
April 2006 wounds 55%, stab wounds 27%, lacerations events
18%.
Kragh et al., 200827 U.S. military March 2006 to 232 95% male, mean age of 29 years, range Deaths, amputations,
Iraq Oct 2006 (194 w/tourniquet) 4–70 years, 9 children and 1 elderly. Injuries: adverse events
explosion 63%, gunshot 23%.
Lakstein et al., 200333 Israeli military Jan 1997 to 91 (improvised Gender and mean age not reported. Injuries: Deaths, amputations,
Jan 2001 tourniquets) explosion 73%, gunshot 27%. adverse events
167
168 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
use were collected and the outcomes reported by each the large effect size and Very Low for amputation rate
study. The large majority of studies were conducted (Table 2).
by the U.S. military in Iraq and Afghanistan (8 stud- There were no studies available that directly ad-
ies) with 3 studies from the U.K. military, 2 from the dressed PICOTS questions 2, 3, and 4. These included
Israeli military, and 1 from Canadian military. Only 1 the efficacy of junctional hemorrhage control devices
study was conducted in a civilian setting. One study or the comparison of different brand or models of
used data on pediatric casualties described in the Joint tourniquets. Regarding PICOTS question 5, there were
Theater Trauma Registry and collected during the wars 4 studies that correlated duration of tourniquet use
in Iraq and Afghanistan.28 Thirteen of the 16 included with adverse events but specifics were not provided on
studies reported data on deaths, 11 reported data on the timing and setting of tourniquet removal.27,30,32,33
adverse events, 8 reported data on amputations, and Thus, the grade of evidence for PICOTS question 5 was
none reported data on shock. rated as Low.
Eight of the studies used prospective data collec-
tion. Most of the studies provided some information
on how the tourniquets were to be used, but only a
Hemostatic Agents
few were specific about the instructions. However, the Seven studies were reviewed that reported on the
studies from the U.S. military were using TCCC prac- prehospital use of hemostatic dressings (Table 3). Five
tices when data were collected after 2005 and tourni- were conducted in a military setting. One was civilian
quets were likely used aggressively as a first option for and 1 included both military and civilian data. The
traumatic extremity hemorrhage. products tested included HemCon (3 studies), Celox (1
Comparisons between casualties treated with a study), QuickClot granules (2 studies), and QuickClot
tourniquet and similar casualties not treated with a Gauze (1 study). One study did not report the type
tourniquet were attempted by only a few studies. Kot- of hemostatic dressings used. Only 1 study reported
wal et al.29 reported the number of casualties treated mortality and 4 studies reported on adverse events.
with compression dressings but did not report out- No studies provided a direct comparison between
comes for this group. Beekley et al.30 reported out- the use of hemostatic dressings and simply applying
come data for tourniquet- and nontourniquet-treated direct pressure to the wound. The primary adverse
casualties but did not report what prehospital treat- event noted was pain and discomfort associated with
ments the nontourniquet group received. Clasper an exothermic reaction to QuickClot granules.
et al.31 matched surviving tourniquet-treated casual- The primary outcome for 5 studies was cessation
ties with surviving nontourniquet-treated casualties of bleeding. The study by Brown et al.34 reported that
to examine the rate of adverse events. These au- HemCon controlled external hemorrhage in 27 of 34
thors note, however, that “in a standard retrospec- cases (79%); in 25 cases the bleeding stopped within 3
tive study it is likely that there would be consider- minutes of application. The study by Cox et al.35 is con-
able bias if simple comparison was made between the founded because 7 of the 8 patients treated with hemo-
two groups as it is likely that those casualties with static dressings in the field were also treated with a
more severe injuries would have required a tourni- tourniquet. The study by Pozza and Millner36 reported
quet, but those with a more severe injury are also that Celox stopped bleeding in 18 gunshot wounds
likely to have worse outcomes and experience more when first applied and in 3 additional cases with
complications.”31 further application. The study by Ran et al.37 reported
Meta-analysis of the 9 studies reporting survival that QuickClot gauze successfully stopped bleeding in
for adult military casualties treated with tourniquets 11 out of 14 cases of extremity and truncal hemorrhage.
demonstrated a summary effect size estimate for sur- The study by Rhee et al.38 reported that QuickClot
vival rate of 92% with 95% confidence intervals of granules were 100% effective in stopping bleeding. In
88–95%. Findings in the study of children were simi- the study by Wedmore et al.,39 medics were surveyed
lar (92%, with CI 84–96%). The study of a civilian pop- on their use of HemCon dressing. In 42 of the 64
ulation was small (11 cases), so the confidence inter- cases, the dressings were used when traditional gauze
val was wide, but the survival rate similar (91%, CI dressings or pressure dressings failed to stop bleeding.
56–99%). A similar analysis for 6 studies reporting am- In 62 of the 64 cases, HemCon successfully stopped
putation rates demonstrated a summary effect size es- the bleeding. The risk of bias associated with these
timate of 19% with a 95% confidence interval from studies is high because they are all single-arm studies
16–23%. These amputations are presumably primar- with no comparison group. Sufficient data were not
ily associated with the severity of the extremity injury, available to provide an estimate of survival rates or
as they are not described as complications of tourni- amputation rates in patients treated with hemostatic
quet use. The overall quality of the evidence for PI- dressings. The overall strength of evidence for Key
COTS Question 1 was rated using the GRADE system Question 6 was graded as Low using the GRADE
as Moderate for survival based on upgrading due to system.
TABLE 2. Key Question 1: Strength of evidence grades for survival rate and amputation rate with prehospital tourniquet use
Decrease GRADE Increase GRADE
GRADE of
# Studies Type of Starting evidence for
Study limitations
Consistency
Directness
Precision
Publication bias
Large magnitude of effect
Dose-response
Confounders
Survival rate 9 studies of Observational 91.9% (95% Low −1 Absence of 0 0 0 0 +2 (7-fold 0 0 Moderate
military confidence interval comparison group improvement over
personnel [CI]: 88.1% to historical military
(1,229) 94.6%) data)
Amputation rate 6 (556) Observational 19.2% (95% CI: Low −1 Absence of 0 0 0 0 0 0 0 Very Low
15.8% to 23.2%) comparison group
169
170 PREHOSPITAL EMERGENCY CARE APRIL/JUNE 2014 VOLUME 18 / NUMBER 2
Brown et al., 200934 U.S. civilian June 2006 to Aug 2006 HemCon n = 34 53% extremity wounds, 68%
male, mean age of
51.5 years, range of
16–91 years.
Cox et al., 200935 U.S. military April 2006 to Oct 2006 HemCon n = 5, QuikClot 7 of 8 extremity wounds,
Iraq granules n = 3 other data not reported.
Lairet et al., 201220 U.S. military Nov 2009 to Nov 2011 Not specified n = 23, For all 1,003 patients in the
Afghanistan Compression n = 371 study, the mechanism of
injury was explosion 60%,
penetrating 24%, blunt
15%. 97% male, mean age
of 25 years.
Pozza and Millner, 201036 U.S. military April 2008 to April 2008 Celox = 21 All gunshot wounds. All
Afghanistan male between ages of 18
and 45 years.
Ran et al., 201037 Israel military 2009 Quikclot Combat Gauze n = Injuries: blast = 7, gunshot =
14 6, stab = 1. Other data not
reported.
Rhee et al., 200838 U.S. civilian and U.S. Not specified, but study QuikClot granules n = 103 Injuries for all patients:
military was completed in 2006 (69 treated by U.S. military explosion 21%, gunshot
Iraq personnel, 20 treated by 66%, blunt 8%, stab wound
civilian trauma surgeons, 5%.
14 treated by civilian first
responders)
Wedmore et al., 200639 U.S. military 2003 to 2004 HemCon n = 64 55% extremity wounds;
Iraq/Afghanistan bleeding was
predominantly from a
venous source in 33 cases,
arterial source in 7 cases,
and unknown in 24 cases.
In regard to PICOTS Question 7, there were no large effect size. The evidence for preventing ampu-
patient studies that directly compared the different tation was very low, due to a smaller effect size and
hemostatic dressings. The U.S. military has developed issues relating to confounding (see Table 2).
a standardized swine model, which involves a femoral Remarks: The panel believes that tourniquets used to
artery injury with a standard period of free bleeding. treat severe extremity hemorrhage have a clear sur-
This literature was summarized and reviewed by the vival benefit, demonstrated by a large and consistent
expert panel. For the details of this review please see effect size across several studies. The panel discussed
the full ECRI Institute report. These data factored into that direct pressure may be ineffective in the set-
the recommendation by the panel for the use of a gauze ting of major arterial injury or impractical in circum-
format product that could be packed into the wound. stances with limited manpower, unsecure scene, or
The panel also supported the use of this standardized when complex extrication or extraction is required.
model for comparison of different products.
Recommendation 2: We suggest using commercially
RECOMMENDATIONS BY EXPERT PANEL produced windlass, pneumatic, or ratcheting devices
that have been demonstrated to occlude arterial flow.
The recommendations of the panel for management of
external hemorrhage are summarized in Figure 2.
Strength of Recommendation: Weak
Quality of Evidence: Low
Tourniquets Remarks: The panel discussed the military experi-
ence with varying types of tourniquets and felt that
Recommendation 1: We recommend the use of tourni-
tourniquet selection should be based on proven ef-
quets in the prehospital setting for the control of sig-
fectiveness at arterial occlusion. Tourniquets that im-
nificant extremity hemorrhage if direct pressure is in-
pede venous return without adequate arterial oc-
effective or impractical.
clusion may only worsen hemorrhage and increase
complications.
Strength of Recommendation: Strong
Quality of Evidence: Moderate. The overall quality of
the evidence for survival benefits of tourniquet use Recommendation 3: We suggest against the use of nar-
was upgraded from Low to Moderate, based on the row, elastic, or bungee-type devices.
E. M. Bulger et al. PREHOSPITAL GUIDELINE FOR EXTERNAL HEMORRHAGE CONTROL 171
further study, but did not find sufficient evidence to NEED FOR ADDITIONAL RESEARCH
make a recommendation at this time.
While the military data were convincing that the use
of tourniquets to control severe extremity hemorrhage
Topical Hemostatic Agents is life saving, there remain several unanswered ques-
Recommendation 1: We suggest the use of topi- tions regarding the logistics of hemorrhage control in
cal hemostatic agents, in combination with direct the civilian EMS community. The evidence available
pressure, for the control of significant hemorrhage to assess many of the practical issues surrounding the
in the prehospital setting in anatomic areas where use of tourniquets and hemostatic agents in the civil-
tourniquets cannot be applied and where sustained di- ian community is very limited. There were insuffi-
rect pressure alone is ineffective or impractical. cient data to make any recommendations regarding the
newly developed devices for junctional hemorrhage
Strength of Recommendation: Weak control. There were insufficient data to make any spe-
Quality of Evidence: Low cific recommendations regarding application in the ex-
Remarks: While the evidence was low, there are con- tremes of age including pediatric and elderly patients.
sistent data from animal models, suggesting reduced Future research should focus on these gaps in knowl-
hemorrhage with these agents compared to standard edge to further guide clinicians in the civilian applica-
gauze and the committee felt that junctional hemor- tion of these products.
rhage and torso wounds may benefit from the com-
bination of direct pressure and hemostatic dressings. References
1. Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe
Recommendation 2: We suggest that topical hemostatic P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussem TE,
agents be delivered in a gauze format that supports Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H,
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