Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511778
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
sTErnAl heMostasiS Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
sTErnAl heMostasiS Trial TEAMS Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None