Reducing sternal bleeding during open-chest heart surgery
sTErnAl heMostasiS Trial (TEAMS Trial)
PHASE4 · WakeMed Health and Hospitals · NCT06511778
This trial will try applying HEMOBLAST, a topical hemostatic agent, to the sternal edges in adults having on-pump open-chest heart surgery who are at higher risk for sternal bleeding to see if it reduces bleeding and chest tube output.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | WakeMed Health and Hospitals (other) |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06511778 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized 1:1 trial enrolling 60 adults (30 HEMOBLAST, 30 control) undergoing on-pump median sternotomy for cardiothoracic surgery. Participants who meet at least one predefined bleeding-risk criterion will be randomized to receive topical HEMOBLAST applied to the sternal edges or usual care, with electrocautery and vancomycin paste allowed as routine adjuncts. Sternal bleeding will be scored by both the surgeon and the assisting cardiothoracic PA-C using the SPOT GRADE before and after application, and chest tube output will be measured at 6, 12, and 24 hours postoperatively. Demographic and clinical data will be collected and all subjects will be followed through hospital discharge for bleeding-related complications.
Who should consider this trial
Good fit: Adults aged 21 or older scheduled for on-pump median sternotomy who can give informed consent and have at least one risk factor for sternal bleeding (redo sternotomy, platelet count <150, recent dual antiplatelet therapy, BMI >35, combined CABG/valve surgery, or CKD/ESRD).
Not a fit: Patients undergoing a thoracotomy approach, those without the listed risk factors, and pregnant or nursing individuals are not eligible and therefore unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, the intervention could reduce sternal bleeding, lower blood loss and operative time, and decrease postoperative chest tube output.
How similar studies have performed: Topical hemostatic agents have shown benefit in various surgical settings, but high-quality randomized data specifically targeting sternal bleeding are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Raleigh, North Carolina
- WakeMed Health and Hospitals — Raleigh, North Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Excessive Bleeding During Surgery