Clinical trial NCT06511778: sTErnAl heMostasiS Trial
Official title: sTErnAl heMostasiS Trial (TEAMS Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Excessive Bleeding During Surgery
Lead sponsor: WakeMed Health and Hospitals
Sponsor class: OTHER
Collaborators: name: Dilon Technologies
First posted: 2024-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing on pump sternotomy surgery
Primary purpose: PREVENTION

Brief 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.

Detailed 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 their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.

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.

Primary outcomes:
measure: Sternal Bleeding Score
timeFrame: Sternotomy creation
measure: Sternal Bleeding Score
timeFrame: Sternal closure
measure: Reoperation for Bleeding
timeFrame: Through hospitalization, average of 6 days
measure: Chest Tube Output
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Chest Tube Output
timeFrame: 12 and 24 hours postoperatively
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: WakeMed Health and Hospitals
state: North Carolina
Study officials:
References:
citation: HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
citation: Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
citation: Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447.
citation: Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4.