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

NCT ID: NCT05756426

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2029-01-30

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.

Detailed Description

Previous blood substitutes have failed for 3 main reasons. (1) dysfunctional oxygen interactions resulting from fixed oxygen affinity, allowing adequate oxygen capture in the lungs, but poor oxygen release to tissue (i.e., oxygen affinity is not context responsive to physiologic cues of perfusion sufficiency such as pH, etc.), (2) interference with normal regulation of blood vessel caliber, with inappropriate trapping of the endogenous vasodilator nitric oxide resulting in intense vasoconstriction and tissue ischemia, and (3) inability to maintain hemoglobin functionality during circulation, with hemoglobin auto-oxidizing to methemoglobin which cannot carry and deliver oxygen, thus resulting in a drastically limited effective circulation time.

The individual artificial blood components, which will form the whole blood analog in this proposal, have been designed to overcome these previous design flaws. In addition, all components are amenable to facile reconstitution after extended, ambient dry storage, allowing sustained shelf stability.

In short, these components are ripe for integration to form a product recapitulating natural blood performance.

This study will use data and specimens collected under this protocol and will prospectively enroll new subjects at UMB for observational study. There will not be issues related to the probability of group assignment, the potential for subject to be randomized to a placebo group or the use of controlled substances.

There is only one cohort involved in this study

1. Prospective healthy adults (UMB only)

Conditions

Hemorrhage; Hemodynamic Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

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

Prospective

Intervention Type: OTHER

Single arm, healthy adult volunteers for blood donation.

Interventions

Prospective

Single arm, healthy adult volunteers for blood donation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Stephen Rogers

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Rogers, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Baltimore (UMB)

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Rogers, PhD

Role: CONTACT

stephen.rogers@som.umaryland.edu

410-706-7094

Tobi Rowden, RN

Role: CONTACT

trowden@som.umaryland.edu

410-706-7094

Facility Contacts

Stephen Rogers, PhD

Role: primary

stephen.rogers@umaryland.som.edu

Other Identifiers

HP- 00104380

Identifier Type: -

Identifier Source: org_study_id