Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma

PHASE2CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Blunt TraumaPenetrating WoundHemorrhagic Shock
Interventions
DRUG

0.9% Sodium Chloride 250 mL bolus

Emergency Medicine Systems (EMS) agencies and in-hospital providers will be given the option to utilize either systolic blood pressure (SBP) or radial pulse as the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients will receive a 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS will be given to keep the vein open. The presence or absence of a radial pulse or the SBP will be documented before and after each bolus. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.

DRUG

0.9% Sodium Chloride 2000 mL bolus

Emergency Medicine Systems (EMS) personnel and in-hospital providers will utilize the systolic blood pressure SBP as the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. If the total fluid resuscitation exceeds 2 liters, fluid will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. The fluid will be given as rapidly as possible. This fluid resuscitation protocol will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.

Trial Locations (6)

15261

The Pittsburgh Resuscitation Network, University of Pittsburgh, Pittsburgh

35294

Alabama Resuscitation Center, University of Alabama, Birmingham

53226

Milwaukee Resuscitation Network, Medical College of Wisconsin, Milwaukee

75390

Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center, Dallas

97239

Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University, Portland

V5Z 1M9

Resuscitation Outcomes Consortium Regional Coordinating Center,University of British Columbia, Vancouver

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

University of Washington

OTHER

NCT01411852 - Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma | Biotech Hunter | Biotech Hunter