Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma

NCT04912232 | Terminated Results FDA Device

• 1 other identifier: STUDY02001495
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH with an acceptable rate of false-positives and false-negatives would save countless lives. Additionally, such technology would save significant time, money and effort by allowing medical resources to be applied more accurately - the essence of precision medicine. An automated system would monitor currently stable patients continuously, leaving clinicians free to care for patients in need of attention.

Conditions

Occult Bleeding; Hemorrhage

Keywords

Occult Bleeding; Hemorrhage; Hemorrhagic Shock; Trauma Injury; Precision Medicine; Triage; Bioimpedance; Electrical Impedance Tomography; Electrical Impedance Spectroscopy; Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (5)

• Algorithm Performance: Time of Alarm Before Onset of Deterioration

  patient data will be collected over 3-6 hours

• Algorithm Performance: Sensitivity as Measured by for Alarm/no Alarm Outcome

  patient data will be collected over 3-6 hours

• Algorithm Performance: Specificity as Measured by for Alarm/no Alarm Outcome

  patient data will be collected over 3-6 hours

• Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome

  patient data will be collected over 3-6 hours

• Algorithm Performance: Negative Predictive Value for Alarm/no Alarm Outcome

  patient data will be collected over 3-6 hours

Study Arms (1)

Trauma Patients

EXPERIMENTAL

Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage: 1. Awake and alert GCS \>14 2. Admission systolic blood pressure greater than 90 and heart rate less than 120 3. 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)

Device: Detection of Occult Hemorrhage in Trauma Patients

Interventions

Detection of Occult Hemorrhage in Trauma Patients DEVICE

Non-invasive monitoring of trauma patients

Trauma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• United States Department of Defense: collaborator
• Dartmouth College: collaborator
• Baystate Medical Center: collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (8)

• Shackelford SA, Colton K, Stansbury LG, Galvagno SM Jr, Anazodo AN, DuBose JJ, Hess JR, Mackenzie CF. Early identification of uncontrolled hemorrhage after trauma: current status and future direction. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S222-7. doi: 10.1097/TA.0000000000000198. No abstract available.

  PMID: 24770559 BACKGROUND

• Parks JK, Elliott AC, Gentilello LM, Shafi S. Systemic hypotension is a late marker of shock after trauma: a validation study of Advanced Trauma Life Support principles in a large national sample. Am J Surg. 2006 Dec;192(6):727-31. doi: 10.1016/j.amjsurg.2006.08.034.

  PMID: 17161083 BACKGROUND

• Wo CC, Shoemaker WC, Appel PL, Bishop MH, Kram HB, Hardin E. Unreliability of blood pressure and heart rate to evaluate cardiac output in emergency resuscitation and critical illness. Crit Care Med. 1993 Feb;21(2):218-23. doi: 10.1097/00003246-199302000-00012.

  PMID: 8428472 BACKGROUND

• Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.

  PMID: 21795890 BACKGROUND

• Convertino VA. Blood pressure measurement for accurate assessment of patient status in emergency medical settings. Aviat Space Environ Med. 2012 Jun;83(6):614-9. doi: 10.3357/asem.3204.2012.

  PMID: 22764618 BACKGROUND

• Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.

  PMID: 24637618 BACKGROUND

• Soller BR, Yang Y, Soyemi OO, Ryan KL, Rickards CA, Walz JM, Heard SO, Convertino VA. Noninvasively determined muscle oxygen saturation is an early indicator of central hypovolemia in humans. J Appl Physiol (1985). 2008 Feb;104(2):475-81. doi: 10.1152/japplphysiol.00600.2007. Epub 2007 Nov 15.

  PMID: 18006869 BACKGROUND

• Belle A, Ansari S, Spadafore M, Convertino VA, Ward KR, Derksen H, Najarian K. A Signal Processing Approach for Detection of Hemodynamic Instability before Decompensation. PLoS One. 2016 Feb 12;11(2):e0148544. doi: 10.1371/journal.pone.0148544. eCollection 2016.

  PMID: 26871715 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Shock, Hemorrhagic; Accidental Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Results Point of Contact

• Title: Norman A. Paradis
• Organization: Dartmouth Health

Norman.A.Paradis@hitchcock.org

(603) 650-7254

Study Officials

• Noman Paradis, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: December 8, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)