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Hemostatic Agent

Hemoblast Bellows for Reducing Bleeding During Heart Surgery

Phase 4
Waitlist Available
Research Sponsored by WakeMed Health and Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled to undergo on-pump open chest cardiothoracic surgery
Patients at least 21 years of age
Must not have
Patients undergoing thoracotomy approach
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours postoperatively
Awards & highlights

Summary

This trial aims to find out if using a special agent on the chest during heart surgery can help reduce bleeding from the breastbone, which is a common issue that causes problems during surgery.

Who is the study for?
This trial is for individuals undergoing cardiac surgery using a sternotomy approach who are experiencing sternal bleeding. Specific eligibility criteria have not been provided, so it's important to contact the study team for detailed information.
What is being tested?
The trial is testing whether applying Hemoblast Bellows, a topical hemostatic agent, can reduce sternal bleeding during open-heart surgeries. It aims to improve operative conditions and patient outcomes.
What are the potential side effects?
Potential side effects of Hemoblast Bellows application may include local reactions at the application site or allergic responses; however, specific side effects are not listed and should be discussed with the research team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for open chest heart surgery with a heart-lung machine.
Select...
I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having or have had surgery through a cut in my chest.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospitalization, average of 6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospitalization, average of 6 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chest Tube Output
Reoperation for Bleeding
Sternal Bleeding Score

Trial Design

2Treatment groups
Active Control
Group I: No Application of Hemoblast Hemostatic AgentActive Control1 Intervention
Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.
Group II: Application of Hemoblast Hemostatic AgentActive Control1 Intervention
Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Find a Location

Who is running the clinical trial?

WakeMed Health and HospitalsLead Sponsor
6 Previous Clinical Trials
3,639 Total Patients Enrolled
Dilon TechnologiesUNKNOWN
~40 spots leftby Aug 2025
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