Study Stopped
Recruitment has been unsuccessful and the study team is withdrawing the study while they consider options and alternatives.
Mediastinal Temperature and Post-operative Bleeding
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
June 21, 2021
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedOctober 28, 2022
October 1, 2022
10 months
June 14, 2021
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Chest temperature
We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
At the end of surgery, up to 5 hours
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
24 hours after the end of surgery
Study Arms (2)
Experimental
EXPERIMENTALthis cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest
Control
NO INTERVENTIONthis cohort will receive the normal standard of care as established by the primary surgeon
Interventions
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
Eligibility Criteria
You may qualify if:
- Patients undergoing open cardiac surgery at VCU
- Age18 to 80 years
- American Society of Anesthesiologists Physical Status 1-3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arturo Cardounel, M.D.
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2021
First Posted
June 21, 2021
Study Start
October 1, 2022
Primary Completion
August 1, 2023
Study Completion
August 1, 2025
Last Updated
October 28, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share