Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05756426
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-02-02
Brief Title:
Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCERT
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 settingsThe 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 ie 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
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 settingsThe 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 ie 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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None