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Cow-Hemoglobin infusion could save lives when blood is not an option

NCT ID NCT03633604

Disease control Sponsor: Michael Boisen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests HBOC-201, an oxygen-carrying fluid made from cow hemoglobin, in adults with life-threatening anemia who cannot receive red blood cell transfusions. Participants have dangerously low hemoglobin levels and signs of oxygen deprivation. The goal is to see if HBOC-201 can temporarily deliver oxygen to tissues and reduce the need for blood transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HBOC-201, also called Hemopure, a hemoglobin-based oxygen carrier made from cow blood
What this could lead to
If it works, HBOC-201 could provide a life-saving oxygen bridge for patients with severe anemia who cannot or will not accept blood transfusions.
What could go wrong
This is an expanded-access study, not a controlled trial, so results may not prove broad effectiveness. HBOC-201 carries risks like high blood pressure and kidney injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥ 18 years of age 2. Critically ill patients with hemoglobin ≤ 6 g/dL (or 7-8 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits 3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent 4. Blood is not an option due to: * refusal of transfusion * lack of compatible red blood cells Exclusion Criteria: 1. Patients with known hypersensitivity or allergy to beef products 2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure (caution should be exercised if renal insufficiency is present), circulatory hypervolemia or systemic mastocytosis\* 3. Patients who are eligible for blood transfusions 4. Patients who are \> 80 years old\* 5. Pregnant or lactating women * on a case by case and quality of life determination

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Conditions

The condition(s) this trial relates to.

anemia hematologic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia severe

Contacts and locations

Locations

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States