Mediastinal Temperature and Post-operative Bleeding
Primary Purpose
Blood Loss, Surgical
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saline irrigation
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing open cardiac surgery at VCU
- Age18 to 80 years
- American Society of Anesthesiologists Physical Status 1-3
Exclusion Criteria:
- history of excessive bleeding
- partial thromboplastin time > 35 s
- prothrombin time > 35 s
- fibrinogen < 200 mg/dL
- platelet count < 100,000/L
- history of infection and fever within 4 weeks before surgery
- use of steroid or immunosuppressant within 4 weeks before surgery
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest
this cohort will receive the normal standard of care as established by the primary surgeon
Outcomes
Primary Outcome Measures
Chest temperature
We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Amount of blood loss
amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT04933253
First Posted
June 14, 2021
Last Updated
October 25, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04933253
Brief Title
Mediastinal Temperature and Post-operative Bleeding
Official Title
Mediastinal Temperature and Post-operative Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment has been unsuccessful and the study team is withdrawing the study while they consider options and alternatives.
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will investigate how chest temperature relates to blood loss and blood clotting. Researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. In addition, researchers will test if warm irrigation of the chest increases the temperature of the chest and if this impacts blood loss.
Detailed Description
Low body temperature during surgery, defined as a temperature below 34 °C, occurs commonly in patients undergoing cardiac surgery due to the bypass machine and an open chest. Low body temperature has been associated with blood loss, but the relevant published data are inconclusive. Nevertheless, evidence suggests that blood loss during and after surgery are higher in low body temperature patients than in the normal body temperature patients. In addition, low body temperature can impair blood clotting. The clinical significance of this is high as it is well established that blood transfusion increases mortality after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest
Arm Title
Control
Arm Type
No Intervention
Arm Description
this cohort will receive the normal standard of care as established by the primary surgeon
Intervention Type
Procedure
Intervention Name(s)
Saline irrigation
Intervention Description
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
Primary Outcome Measure Information:
Title
Chest temperature
Description
We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Time Frame
At the end of surgery, up to 5 hours
Title
Amount of blood loss
Description
amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery
Time Frame
24 hours after the end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing open cardiac surgery at VCU
Age18 to 80 years
American Society of Anesthesiologists Physical Status 1-3
Exclusion Criteria:
history of excessive bleeding
partial thromboplastin time > 35 s
prothrombin time > 35 s
fibrinogen < 200 mg/dL
platelet count < 100,000/L
history of infection and fever within 4 weeks before surgery
use of steroid or immunosuppressant within 4 weeks before surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Cardounel, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mediastinal Temperature and Post-operative Bleeding
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