sTErnAl heMostasiS Trial
sTErnAl heMostasiS Trial (TEAMS Trial)
WakeMed Health and Hospitals
60 participants
Oct 17, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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)
Exclusion Criteria3
- 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.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06511778