Mediastinal Temperature and Post-operative Bleeding

Blood Loss, Surgical Clinical Trial

Official title:

Mediastinal Temperature and Post-operative Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04933253
• Other study ID #: HM20021183
• Status: Withdrawn
• Phase: N/A
• Start date: October 2022
• Est. completion date: August 2025

Study information

• Verified date: October 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2025
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Postoperative Hemorrhage

Intervention

Procedure:
• Saline irrigation
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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