sTErnAl heMostasiS Trial

NCT06511778 | Recruiting Phase 4 FDA Drug

• 1 other identifier: TEAMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Sternal Bleeding Score

  A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding) before and after hemostatic agent application

  Sternotomy creation

• Sternal Bleeding Score

  A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding)

  Sternal closure

• Reoperation for Bleeding

  Patients will be monitored for incidences of reoperation due to bleeding

  Through hospitalization, average of 6 days

• Chest Tube Output

  The patient's chest tube output will be recorded after surgery

  6 hours postoperatively

Secondary Outcomes (1)

• Chest Tube Output

  12 and 24 hours postoperatively

Study Arms (2)

No Application of Hemoblast Hemostatic Agent

NO INTERVENTION

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

Application of Hemoblast Hemostatic Agent

ACTIVE COMPARATOR

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

Drug: Hemoblast Bellows application

Interventions

Hemoblast Bellows application DRUG

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.

Application of Hemoblast Hemostatic Agent

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Undergoing redo sternotomy
• Have a preoperative platelet count \<150 mg/dL
• Are on dual antiplatelet therapy (blood thinners) \< 5 days prior to sternotomy
• Have a BMI (body mass index)\> 35
• Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
• Have chronic kidney disease (GFR \<60 ml/min) or ESRD (end stage renal disease)

You may not qualify if:

• 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.

Sponsors & Collaborators

• WakeMed Health and Hospitals: lead
• Dilon Technologies: collaborator

Study Sites (1)

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

RECRUITING

Related Publications (4)

• HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.

  BACKGROUND

• Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447.

  PMID: 29019803 BACKGROUND

• Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.

  BACKGROUND

• Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4.

  PMID: 34099003 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not know whether they had the hemostatic agent applied during scheduled on pump sternotomy surgery as an additional adjunct to control bleeding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients undergoing on pump sternotomy surgery

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)