Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy

NCT05756426 | Recruiting DMC

• 1 other identifier: HP- 00104380
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

There is need for a whole blood analog for use when banked blood is unavailable or undesirable. In civilian trauma, hemorrhage accounts for \~ 35% of pre-hospital deaths; moreover, \~ 20% of military casualties are in hemorrhagic shock on arrival to field hospitals and an additional 5% require urgent transfusion. A recent review concluded that hemorrhage accounted for \~ 90% of potentially survivable battlefield deaths - lives that could be saved with better hemorrhage control capabilities and improved, field-ready blood, blood components, or blood substitutes. While study of ideal composition for resuscitative fluids is ongoing, it is evident that for those in hemorrhagic shock, volume replenishment alone (without O2 carrying capacity) is insufficient. Alternatively, with massive blood loss or with ongoing bleeding from non-compressible injuries, resuscitation with an O2 carrier alone may be complicated by acquired coagulopathy (either dilutional or trauma-induced). Development of a balanced resuscitation fluid that treats both shock and coagulopathy (comprising a field-deployable O2 carrier with lyophilized humoral hemostatic components and platelets) is essential to allow on-scene treatment during the critical 'golden-hours' after injury. As such, the whole blood analog described herein could be this product, thus transforming care in both civilian and military settings.The scientific purpose of this study is to develop a combined whole blood substitute from individual artificial prototypes that have been separately developed for each blood component (i.e., combining an artificial oxygen carrier, with an artificial plasma analogue and an artificial platelet analogue). Together, these combined components will recapitulate the composition and performance of natural whole blood. Blending and combination experiments of the individual artificial prototypes will be performed to test compatibility and optimize efficacy. State of the art in vitro (bench top) assays will be performed to assess physicochemical and functional performance (hemodynamics, oxygen delivery, hemostasis), with data being compared to experiments performed on fresh and stored whole blood.

Conditions

Hemorrhage; Hemodynamic Instability

Keywords

Hemostasis; Vasoactivity; Oxygen affinity; Red Blood Cell; Whole blood analogue; Perfusion; Nitric Oxide; Methemoglobin

Outcome Measures

Primary Outcomes (2)

• Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood.

  Oxygen delivery capacity will be analyzed by measuring the oxygen disassociation curve and determining and arterial-venous (A-V) delta hemoglobin oxygen saturation. From this an A-V oxygen flux capacity can be determine and matched between stored blood and HBOC.

  4years

• Evaluate performance attributes (PA's) stored whole blood (SWB): fresh whole blood, and WBA:fresh whole blood (FWB) mixtures.

  Compose mixtures of SWB:FWB or WBA:FWB, in ratios consistent of massive transfusions. Quantify (1) oxygen disassociation curve of mixtures across pH ranges of stressed physiology (pH 7.2-7.6). Determine the A-V delta hemoglobin saturation to calculate oxygen flux capacity. (2) viscosity shear relationships and visco elastic behavior will be characterized by rheometry, (3) Nitric oxide (NO) trapping and vasoactivity utilizing a biochemical NO trapping assay and a aortic rings (vascular ring bioassay), (4) hemostasis measuring thromboelastography (TEG).

  4years

Study Arms (1)

Healthy Volunteers

Healthy Volunteers \>/= 18yrs of age without acute or chronic illness.

Other: Prospective

Interventions

Prospective OTHER

Single arm, healthy adult volunteers for blood donation.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This research study intends to enroll 50healthy volunteer subjects/year over the next 5 years (total of 250 subjects).

You may qualify if:

• Subject \>/= 18 years of age
• Subject weighs \>40kg (88lbs)
• Subject must be generally healthy

You may not qualify if:

• Suspected or diagnosed with ongoing (chronic) or acute infection
• Subject is pregnant
• Subject is non-english speaking

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Maryland Baltimore (UMB)

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Healthy Adult Volunteers: Healthy volunteers can be any adult, who meets eligibility criteria and is willing to donate blood for the purpose of this research study. The individual will have 20 milliliters (mL) of blood drawn upon the time of consent. The subject may donate up to 12 times (maximum) per year over the course of their enrollment, no closer together than every 2 weeks (14 days). Only basic demographic data will be collected (i.e., Age, Gender, Ethnicity, History of medical illness (or Primary Diagnosis), weight, and current medications/therapies). The Informed Consent Form Documentation Checklist \& Specimen Collection Checklist will be utilized to ensure eligibility is checked and most recent Informed Consent Form (ICF) is signed prior to specimen collection

MeSH Terms

Conditions

Hemorrhage

Interventions

Longitudinal Studies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stephen Rogers, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Rogers, PhD

CONTACT

410-706-7094; stephen.rogers@som.umaryland.edu

Tobi Rowden, RN

CONTACT

410-706-7094; trowden@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 6, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (1)