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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-88
SponsorUniversity of Maryland, Baltimore

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Subject >/= 18 years of age

Subject weighs >40kg (88lbs)

Subject must be generally healthy

Disqualifiers

Suspected or diagnosed with ongoing (chronic) or acute infection

Subject is pregnant

Subject is non-english speaking

Trial population

This research study intends to enroll 50healthy volunteer subjects/year over the next 5 years (total of 250 subjects).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Prospective

    Other intervention

    Single arm, healthy adult volunteers for blood donation.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Healthy Volunteers1 intervention

Trial outcomes

Primary outcomes

1

Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood.

Oxygen delivery capacity will be analyzed by measuring the oxygen disassociation curve and determining and arterial-venous (A-V) delta hemoglobin oxygen saturation. From this an A-V oxygen flux capacity can be determine and matched between stored blood and HBOC.

Time frame
4years
2

Evaluate performance attributes (PA's) stored whole blood (SWB): fresh whole blood, and WBA:fresh whole blood (FWB) mixtures.

Compose mixtures of SWB:FWB or WBA:FWB, in ratios consistent of massive transfusions. Quantify (1) oxygen disassociation curve of mixtures across pH ranges of stressed physiology (pH 7.2-7.6). Determine the A-V delta hemoglobin saturation to calculate oxygen flux capacity. (2) viscosity shear relationships and visco elastic behavior will be characterized by rheometry, (3) Nitric oxide (NO) trapping and vasoactivity utilizing a biochemical NO trapping assay and a aortic rings (vascular ring bioassay), (4) hemostasis measuring thromboelastography (TEG).

Time frame
4years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

United States Department of Defense

Collaborator