RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-13
Study Completion:2029-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05756426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 88 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject \>/= 18 years of age
  2. * Subject weighs \>40kg (88lbs)
  3. * Subject must be generally healthy
  1. * Suspected or diagnosed with ongoing (chronic) or acute infection
  2. * Subject is pregnant
  3. * Subject is non-english speaking

Contacts and Locations

Study Contact

Stephen Rogers, PhD
CONTACT
410-706-7094
stephen.rogers@som.umaryland.edu
Tobi Rowden, RN
CONTACT
410-706-7094
trowden@som.umaryland.edu

Principal Investigator

Stephen Rogers, PhD
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland Baltimore (UMB)
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

  • Stephen Rogers, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13
Study Completion Date2029-01-30

Study Record Updates

Study Start Date2023-04-13
Study Completion Date2029-01-30

Terms related to this study

Keywords Provided by Researchers

  • Hemostasis
  • Vasoactivity
  • Oxygen affinity
  • Red Blood Cell
  • Whole blood analogue
  • Perfusion
  • Nitric Oxide
  • Methemoglobin

Additional Relevant MeSH Terms

  • Hemorrhage
  • Hemodynamic Instability