Field Pilot Trial of Hypotensive Resuscitation versus Standard Resuscitation in Patients with Hemorrhagic Shock after Trauma

Study ID
STU 052011-081

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Melinda Moffat
214-648-3916
melinda.moffat@utsouthwestern.edu

Principal Investigator
Ahamed Idris

Summary

This is an individually randomized controlled clinical trial. EMS agencies will carry blinded, sealed fluid containers. Once the container seal is broken the patient is randomized. The package will contain either 1000cc bags of normal saline (NS) or 250cc bags of NS. Patients randomized to standard fluid resuscitation will receive 1000cc bags of fluid until 2L have been given rapidly and then they will receive additional fluid to maintain a SBP of 110mmHG. Patients randomized to hypotensive resuscitation will receive 250cc bags of normal saline only if their SBP is and amp;lt;70mmHg or their radial pulse is absent. Study intervention is concluded 2 hours after arrival at the ED or when bleeding is controlled, whichever comes first. If after a patient is enrolled and clinical evidence of severe traumatic brain injury is observed in the field or in the hospital but prior to the designated study stopping points and the patient has a GCS <=8, the randomized resuscitation procedure will be discontinued immediately and routine care will be provided. Post intubation, the verbal component of the GCS score will be assigned a [Double Quote]1[Double Quote], and the GCS eye and motor scores will be obtained after neuromuscular blockade administered during intubation has dissipated. Clinical evidence will be defined as:
Unequal or poorly reactive pupils
Seizure
Decorticate posturing
Decerebrate posturing
Penetrating skull fracture
Depressed skull fracture
Battle[Right Quote]s sign (ecchymosis of the mastoid process of the temporal bone)
Raccoon eyes (periorbital ecchymosis i.e. [Double Quote]black eyes[Double Quote])
Otorrhea (fluid or bleeding from ear)
Rhinorrhea (fluid of bleeding from nose)
Head CT that indicates intracranial hemorrhage, hematoma, contusion, or edema


Letters of notification of participation are provided under the and amp;quot;add supporting documents and amp;quot;.

Participant Eligibility

Blunt or penetrating injury, age >= 15yrs or weight >= 50kg if age is unknown, prehospital SBP ≤ 90.