Observational Study on Bio-Artificial Blood Components for Resuscitation
This observational study, called the Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy, is looking for 250 healthy adult volunteers to donate blood. The goal is to develop a "whole blood analog" (a substitute for real blood) that can deliver oxygen as effectively as stored blood, especially for people experiencing severe bleeding (hemorrhage) or unstable blood flow (hemodynamic instability). Researchers will compare how well this artificial blood works against fresh and stored whole blood. You can join if you are 18 to 88 years old, weigh over 88 pounds, and are generally healthy. You cannot join if you are pregnant or have an infection. This study aims to create a blood substitute for situations where regular blood isn't available or suitable.
- Study design
- This is an observational study involving 250 healthy adult volunteers for blood donation. It is a single-arm study, meaning all participants will be in one group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for this study are measured at 4 years, suggesting a long-term follow-up period.
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Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Stephen Rogers, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood.4years
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.
- Evaluate performance attributes (PA's) stored whole blood (SWB): fresh whole blood, and WBA:fresh whole blood (FWB) mixtures.4years
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).