sTErnAl heMostasiS Trial

sTErnAl heMostasiS Trial (TEAMS Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Excessive Bleeding During Surgery
• Intervention / Treatment: Drug: Hemoblast Bellows application

Detailed Description

This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.

Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.

The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.

All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed Health and Hospitals
      • Contact: Rhonda D Norton; Phone Number: 919-350-5252; Email: rnorton@wakemed.org
      • Principal Investigator: Judson B Williams, MD
      • Contact: LaMonica Daniel; Phone Number: 919-350-7438; Email: ladaniel@wakemed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest Tube Output	The patient's chest tube output will be recorded after surgery	12 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: WakeMed Health and Hospitals
• Collaborators: Dilon Technologies

Publications and helpful links

General Publications

• HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
• Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TEAMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes