RECRUITING

sTErnAl heMostasiS Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

sTErnAl heMostasiS Trial (TEAMS Trial)

Quick Facts

Study Start:2024-10-17

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Locations (Sites)

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610

United States

Collaborators and Investigators

Sponsor: WakeMed Health and Hospitals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-10-17

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Excessive Bleeding During Surgery