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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Withdrawn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
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 14, 2021
Last Updated
October 25, 2022
Sponsor
Virginia Commonwealth University
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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Withdrawn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

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Mediastinal Temperature and Post-operative Bleeding

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