New gel could stop bleeding during heart surgery
NCT ID NCT06511778
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This trial tests a gel-like hemostatic agent called Hemoblast bellows to reduce bleeding during heart surgery. About 60 adults undergoing open-heart surgery will receive the gel on their breastbone. Researchers will measure bleeding scores and chest tube output to see if it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hemoblast bellows (a topical hemostatic agent)
- What this could lead to
- If it works, this could provide a simple way to control bleeding during heart surgery, reducing complications and recovery time.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. The results may not apply to all patients, and the agent may not significantly reduce bleeding.
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.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Patients are scheduled to undergo on-pump open chest cardiothoracic surgery. * Patients must be willing and able to provide written informed consent. * If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure. * Patients must be at least 21 years of age. * Patients have at least one of the following risk factors: 1. Undergoing redo sternotomy 2. Have a preoperative platelet count \<150 mg/dL 3. Are on dual antiplatelet therapy (blood thinners) \< 5 days prior to sternotomy 4. Have a BMI (body mass index)\> 35 5. Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery 6. Have chronic kidney disease (GFR \<60 ml/min) or ESRD (end stage renal disease) Exclusion Criteria: * Patients who undergo thoracotomy approach * Patients who are not deemed an appropriate candidate by the investigator. * Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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WakeMed Health and Hospitals
RECRUITINGRaleigh, North Carolina, 27610, United States