2024-27679. Supplemental Evidence and Data Request on Prehospital EMS Blood Transfusion and Fluid Interventions for Hemorrhagic Shock

Preliminary PICOTS Criteria

PICOTS	Inclusion criteria	Exclusion criteria
Populations	• Patients requiring prehospital hemorrhagic shock resuscitation treated in the prehospital setting by emergency medical services clinicians	• Individuals who do not require prehospital hemorrhagic shock resuscitation. • Individuals not treated by emergency medical services clinicians.
Intervention	• KQ1: whole blood	• Other types of resuscitation.
	• KQ2: PRBCs
	• KQ3: plasma ( e.g., fresh frozen, liquid, dried, etc.)
	• KQ4: crystalloid fluids
	• KQ5: strategies as specified in each publication
	• KQ6: NA
	• CQ1: NA
Comparator	• KQ1 to 4	• KQ1 to KQ5: no comparison.
	○ Head-to-head comparisons between transfusion options to treat prehospital hemorrhagic shock patients
	○ Comparison to usual care as specified in each publication in another group or time period
	• KQ5: strategies as specified in each publication
	• KQ6: NA
	• CQ1: NA
Outcomes	Patient Health Outcomes (highest priority)	• Cost-effectiveness, other outcomes.
	• Mortality/survival
	○ To arrival at hospital
	○ To hospital discharge
	○ Any period less than or equal to 30 days post-emergency
	• Morbidity after discharge
( print page 93295)
	○ Glasgow Outcome Scale, Glasgow Outcome Scale Extended, Modified Rankin Scale, Cerebral Performance Category
	• Length of stay
	○ Hospital free days
	○ ICU free days
	Intermediate Outcomes in the prehospital or ED setting
	• Physiological indicators (including but not limited to the following)
	○ Systolic blood pressure
	○ Diastolic blood pressure
	○ Mean arterial pressure
	○ Heart rate
	○ Respiratory rate
	○ Respiratory failure
	○ ROSC
	○ Shock index
	○ Body temperature
	○ End tidal CO2 (EtCO2)
	○ Level of Consciousness
	GCS
	AVPU
	○ Blood lactate level
	Process Outcomes
	• Time from EMS arrival to initial transfusion of blood product or infusion of crystalloid fluid
	• Amount of blood product transfused or crystalloid fluid infused (total: prehospital and hospital) vs. (hospital only)
	Adverse Events/Harms (including but not limited to the following)
	• Allergic reaction
	• Febrile nonhemolytic reaction
	• Acute hemolytic reaction
	• Transfusion-related acute lung injury [TRALI]
	• Transfusion-associated circulatory overload [TACO]
	• Infection
	• Fluid overload
	• Citrate toxicity
	• Delay to definitive care based on arrival time
	• Isoimmunization
	• Hemolysis
	• Harms related to the method of administration
	• Risk of clotting when Ringer's lactate solution combined with blood
Timing	• Outcomes up to 30 days post-injury	• Outcomes more than 30 days post-injury.
Setting	• Prehospital • US and International studies published in English language from Very High and High HDI a countries.	• ED. • Inpatient, surgery. • Studies conducted in countries rated less than High in the HDI a .
Study Design	• RCTs	• Systematic reviews (we will use reference lists to identify studies for possible inclusion).
	• Prospective comparative studies	• Case series.
	• Retrospective comparative studies	• Descriptive studies.
	• Case control studies	• Letters to the editor.
	• Before/after studies	• Opinion papers.
	• Time series	• Studies published prior to 1990, to focus on contemporary evidence and practices relevant to current prehospital hemorrhagic shock resuscitation protocols.
	• For CQ1 only: qualitative studies that specifically collect data about barriers to and facilitators of implementing prehospital blood product transfusion programs ( e.g., descriptive case studies, evaluations, QI reports), interviews, focus groups
Abbreviations: AVPU = Alert, Voice, Pain, Unresponsive; CQ = Contextual Question; ED = emergency department; EMS = emergency medical services; GCS = Glasgow Coma Scale; HDI = Human Development Index; ICU = intensive care unit; KQ = Key Question; NA = not applicable; PICOTS = population, interventions, comparators, outcomes, timing, and setting; PRBC = packed red blood cell; QI = quality improvement; RCT = randomized controlled trial; ROSC = return of spontaneous circulation.
a  United Nations Development Programme. Human Development Index. Retrieved from https://hdr.undp.org/​data-center/​human-development-index#/​indicies/​HDI.