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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05756426
Status
Recruiting
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Conditions

  • Hemodynamic Instability
  • Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Accepted

Interventions

  • Prospective — OTHER
    Single arm, healthy adult volunteers for blood donation.

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
Oct 2025
Primary completion
Jan 30, 2028
Completion
Jan 30, 2029

Study Design

Enrollment
250 participants (estimated)

Arms

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

Primary Outcome Measure

Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood. [ Time Frame: 4years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore (UMB)BaltimoreMaryland21201
Stephen Rogers, PhD
[email protected]

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By research site
University of Maryland Baltimore (UMB)· Baltimore, MD

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