Mediastinal Temperature and Post-operative Bleeding

Not Applicable

Withdrawn

• Conditions: Blood Loss, Surgical
• Interventions: Procedure: Saline irrigation

• Registration Number: NCT04933253
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-21
• Status Verified: 2022-10
• Study Start: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-28
• Primary Completion: 2023-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Saline irrigation	this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest

Primary Outcome Measures

Name	Time	Method
Chest temperature	At the end of surgery, up to 5 hours	We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Amount of blood loss	24 hours after the end of surgery	amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States