A 48 Subject Study Using Non-invasive Multi-Technology Measurements for Early Detection of Ongoing Hemorrhage

NCT04814810 | Terminated

• 1 other identifier: STUDY02000394
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. 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 would save countless lives. This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.

Conditions

Occult Bleeding; Hemorrhage; Hemorrhagic Shock

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Non-invasive measurements that will be used for machine learning

  Continuous-wave Near-Infrared Spectroscopy (CW-NIRS)

  2-3 hours

• Non-invasive measurements that will be used for machine learning

  Electrical Impedance Tomography

  2-3 hours

• Non-invasive measurements that will be used for machine learning

  Electrical Impedance Spectroscopy

  2-3 hours

• Non-invasive measurements that will be used for machine learning

  Intrathoracic Hemodynamic Bioreactance Signatures

  2-3 hours

Eligibility Criteria

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

Study Population

Patients undergoing liver resection

You may qualify if:

• Adults 18 years or older
• Patients undergoing liver resection.
• Ability to give informed consent.

You may not qualify if:

• Pre-existing systemic illness, likely to alter systemic cardiovascular response to hemorrhage. 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
• Ohio State University: collaborator
• Dartmouth College: collaborator

Study Sites (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, 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; Multiple Trauma; Wounds, Nonpenetrating

Condition Hierarchy (Ancestors)

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

Study Officials

• Norman A Paradis, MD

  Dartmouth-Hitchcock Medical Center

  STUDY DIRECTOR

• Mary Dillhoff, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Ryan Halter, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Vikrant Vaze, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• Jonathan Elliott, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery; Emergency Medicine Physician

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: February 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Locations

US (1)