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Hemostatic Agent

Application of Hemoblast Hemostatic Agent for Postoperative Hemorrhage

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 are scheduled to undergo on-pump open chest cardiothoracic surgery.
* Patients must be willing and able to provide written informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sternal closure
Awards & highlights

Summary

Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 hours postoperatively for reporting.

Treatment Details

Study Objectives

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

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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