NCT05756426 Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
| NCT ID | NCT05756426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-04-13 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-04-13 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stephen Rogers, PhD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT05756426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05756426 currently recruiting?
Yes, NCT05756426 is actively recruiting participants. Contact the research team at stephen.rogers@som.umaryland.edu for enrollment information.
Where is the NCT05756426 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05756426 clinical trial?
NCT05756426 is sponsored by University of Maryland, Baltimore. The principal investigator is Stephen Rogers, PhD at University of Maryland, Baltimore. The trial plans to enroll 250 participants.