Mediastinal Temperature and Post-operative Bleeding

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.

Study Overview

• Status: Withdrawn
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Procedure: Saline irrigation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest	Procedure: Saline irrigation; Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
No Intervention: Control; this cohort will receive the normal standard of care as established by the primary surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Arturo Cardounel, M.D., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical; Postoperative Hemorrhage
• Other Study ID Numbers: HM20021183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No