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sTErnAl heMostasiS Trial
RecruitingPhase 4
sTErnAl heMostasiS Trial (TEAMS Trial)
Who can join
Ages 21 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Hemoblast Bellows application (drug)
Sponsor: WakeMed Health and Hospitals · Participants: 60 · Started: Oct 17, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06511778
Locations in the U.S.
| North Carolina | WakeMed Health and Hospitals, Raleigh |
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.