HemorrhageCONCERTNCT05756426
Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
An observational study of Hemorrhage and Hemodynamic Instability, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Hemodynamic Instability
- What is being tested?
- Prospective
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 30 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This research study intends to enroll 50healthy volunteer subjects/year over the next 5 years (total of 250 subjects).
Who may be able to join
- Subject >/= 18 years of age
- Subject weighs >40kg (88lbs)
- Subject must be generally healthy
Who cannot join
- Suspected or diagnosed with ongoing (chronic) or acute infection
- Subject is pregnant
- Subject is non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore (UMB)
Baltimore, Maryland, 21201
About this study
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).
Read more
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.
Read the 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 (i.e., 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
- Prospective healthy adults (UMB only)
- Conditions
- Hemorrhage, Hemodynamic Instability
- Being tested
- Prospective
- Keywords
- Hemostasis, Vasoactivity, Oxygen affinity, Red Blood Cell, Whole blood analogue, Perfusion, Nitric Oxide, Methemoglobin
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProspectiveOther
Single arm, healthy adult volunteers for blood donation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy Volunteers >/= 18yrs of age without acute or chronic illness. Receives: Other: Prospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4years
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).
Measured: 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start13 Apr 2023
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Stephen Rogers, University of Maryland, Baltimore
- Investigators
- Stephen Rogers, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756426
- Sponsor's protocol ID
- HP- 00104380
- Acronym
- CONCERT
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy
- ClinicalTrials.gov ID
- NCT05756426
- Acronym / sponsor ID
- CONCERT / HP- 00104380
- Conditions
- Hemorrhage, Hemodynamic Instability
- Keywords
- Hemostasis, Vasoactivity, Oxygen affinity, Red Blood Cell, Whole blood analogue, Perfusion, Nitric Oxide, Methemoglobin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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
- Prospective healthy adults (UMB only)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: ProspectiveHealthy Volunteers >/= 18yrs of age without acute or chronic illness. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This research study intends to enroll 50healthy volunteer subjects/year over the next 5 years (total of 250 subjects).
Key inclusion criteria (3 listed)
- Subject >/= 18 years of age
- Subject weighs >40kg (88lbs)
- Subject must be generally healthy
Key exclusion criteria (3 listed)
- Suspected or diagnosed with ongoing (chronic) or acute infection
- Subject is pregnant
- Subject is non-english speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProspectiveSingle arm, healthy adult volunteers for blood donation. | Other | Healthy Volunteers |
Primary outcome
Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood.
Time frame: 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.
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hemorrhage
Recruiting
Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
Fallers Aged 60 Years and Older, Biomarkers / Blood
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Enrolling by invitationEarly Phase 1
Clinical Safety and Efficacy Evaluation of the Blood-cooling and Stasis-removing Formula as an Adjunct to Atorvastatin in the Treatment of Hemorrhagic Moyamoya Disease.
Moyamoya Disease
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Rogers, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Hemodynamic Instability, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the hemoglobin based oxygen carrier (HBOC) amount in the whole blood analogue (WBA) that has the same oxygen delivery capacity as stored blood. (time frame: 4years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.