Excessive Bleeding During Surgery
Conditions
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.
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.
Sponsors
Dilon Technologies
WakeMed Health and Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The patient will not know whether they had the hemostatic agent applied during scheduled on pump sternotomy surgery as an additional adjunct to control bleeding.
Intervention model description
Patients undergoing on pump sternotomy surgery
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Bleeding Score | Sternotomy creation | 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) before and after hemostatic agent application |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Chest Tube Output | 12 and 24 hours postoperatively | The patient's chest tube output will be recorded after surgery |
Countries
United States
Outcome results
None listed