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NCT05756426 · ClinicalTrials.gov registry record
Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
A clinical trial of Hemorrhage and Hemodynamic Instability, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT05756426 is a study of Hemorrhage and Hemodynamic Instability that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 250 participants, roughly in line with the 254-participant average among 20 other Hemorrhage trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT05756426, a study of Hemorrhage and Hemodynamic Instability, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study 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 wi
Conditions Studied
Interventions
- OTHER Prospective
Study Locations (1)
Maryland
- University of Maryland Baltimore (UMB) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-04-13 |
| Est. Completion | 2029-01-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05756426
The ClinicalTrials.gov registry entry for NCT05756426 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 254-participant average among 20 other Hemorrhage trials with a reported enrollment target. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemorrhage appearing as the primary indexed condition, and to 1 intervention - of which Prospective is the first listed.
NCT05756426 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05756426 about?
NCT05756426 is a clinical study titled "Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy". 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 urge...
What is the current status of trial NCT05756426?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2023-04-13. Estimated completion is 2029-01-30.
What conditions does trial NCT05756426 study?
This clinical trial studies the following conditions: Hemorrhage, Hemodynamic Instability.
What interventions are being tested in trial NCT05756426?
The interventions under investigation include: Prospective (OTHER).
Who is sponsoring clinical trial NCT05756426?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05756426 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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