sTErnAl heMostasiS Trial

Phase 4

Not yet recruiting

• Conditions: Excessive Bleeding During Surgery
• Interventions: Drug: Hemoblast Bellows application

• Registration Number: NCT06511778
• Lead Sponsor: WakeMed Health and Hospitals

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-22
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Study Start: 2024-08
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Application of Hemoblast Hemostatic Agent	Hemoblast Bellows application	Patients who are randomized to "treatment" will receive application of the Hemoblast hemostatic agent during on pump sternotomy surgery.

Primary Outcome Measures

Name	Time	Method
Sternal Bleeding Score	Sternal closure	A sternal bleeding score will be performed independently by surgeon and physician assistant utilizing the SPOT GRADE bleeding scale ranging from 0-5. 0 (no bleeding), 1 (minimal bleeding), 2 (mild bleeding), 3 (moderate bleeding), 4 (severe bleeding), 5 (extreme bleeding)
Reoperation for Bleeding	Through hospitalization, average of 6 days	Patients will be monitored for incidences of reoperation due to bleeding
Chest Tube Output	6 hours postoperatively	The patient's chest tube output will be recorded after surgery

Secondary Outcome Measures

Name	Time	Method
Chest Tube Output	12 and 24 hours postoperatively	The patient's chest tube output will be recorded after surgery

Trial Locations

Locations (1)

WakeMed Health and Hospitals; 🇺🇸 Raleigh, North Carolina, United States