Status:
TERMINATED
Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
United States Department of Defense
Dartmouth College
Conditions:
Occult Bleeding
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage. Early detection of...
Detailed Description
The investigators will enroll 480 trauma patients in a "no significant risk" prospective clinical trial to 1) evaluate the performance of a Mark I prototype, 2) validate the performance of the Phase I...
Eligibility Criteria
Inclusion
- Awake and alert GCS \>14
- Admission systolic blood pressure greater than 90 and heart rate less than 120
- Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Exclusion
- Altered mental status GCS \< 13
- Systolic blood pressure less than 90 or heart rate greater than 120
- Need for ongoing fluid or pressor support (standard local fluid resuscitation only)
- Clinically significant ongoing external hemorrhage
- Respiratory distress with O2 saturation \<96%
- Pre-existing systemic illness, likely to alter systemic cardiovascular response to hemorrhage (overt clinical heart failure). Including congestive heart failure, and a paced cardiac rhythm.
- Pregnant
- Prisoner status
Key Trial Info
Start Date :
December 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04912232
Start Date
December 8 2022
End Date
December 8 2022
Last Update
May 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baystate Medical Center
Springfield, Massachusetts, United States, 01199