Recruiting

Topical Hemostatic Agent

Sponsor:

WakeMed Health and Hospitals

Code:

NCT06511778

Conditions

Excessive Bleeding During Surgery

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Hemoblast Bellows application

Study Details

Brief 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.

Conditions

Excessive Bleeding During Surgery

Study ID

NCT06511778

Start date

Oct 17, 2024

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: No Application of Hemoblast Hemostatic Agent

Patients who are randomized to "control" will not receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

active comparator: Application of Hemoblast Hemostatic Agent

Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Interventions

Hemoblast Bellows application

Hemoblast bellows is a hemostatic agent clinically proven effective on the validated SPOT GRADE scale for minimal, mild, and moderate bleeding. Patients will have the Hemoblast bellows applied during on pump sternotomy surgery.

Primary outcome measure

  • Sternal Bleeding Score [ Time Frame: Sternotomy creation ]
  • Sternal Bleeding Score [ Time Frame: Sternal closure ]
  • Reoperation for Bleeding [ Time Frame: Through hospitalization, average of 6 days ]
  • Chest Tube Output [ Time Frame: 6 hours postoperatively ]

Central Contacts and Locations

Locations

WakeMed Health and Hospitals

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

LaMonica Daniel

919-350-7438ladaniel@wakemed.org

Rhonda D Norton

919-350-5252rnorton@wakemed.org

Principal Investigator:

Judson B Williams, MD

More Information

Sponsor

WakeMed Health and Hospitals

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WakeMed Health and Hospitals on 2025-09-11.