Systemic Hypothermia in Acute Cervical Spinal Cord Injury

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 4, 2017

Primary Completion Date

August 31, 2026

Study Completion Date

September 30, 2026

Conditions
Spinal Cord Injury, Acute
Interventions
OTHER

Hypothermia

To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification \[510(k), K030421\]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.

Trial Locations (7)

21201

RECRUITING

University of Maryland School of Medicine, Baltimore

29203

RECRUITING

Prisma Health - University of South Carolina, Columbia

33136

RECRUITING

Jackson Memorial Hospital, Miami

85027

RECRUITING

HonorHealth Research Institute with Barrow Brain and Spine, Phoenix

30303-3049

TERMINATED

Emory University School of Medicine, Atlanta

46202-1000

TERMINATED

Indiana University School of Medicine, Indianapolis

19107-5125

RECRUITING

Thomas Jefferson University, Philadelphia

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

University of Miami

OTHER