sTErnAl heMostasiS Trial (TEAMS Trial)
WakeMed Health and Hospitals
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.
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 the…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 ma…
Interventions
- DrugHemoblast 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.
Location
- WakeMed Health and HospitalsRaleigh, North Carolina