Mediastinal Temperature and Post-operative Bleeding

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04933253

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical	Procedure: Saline irrigation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Mediastinal Temperature and Post-operative Bleeding

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT04933253

Other Study ID Numbers:

HM20021183

First Posted:

Jun 21, 2021

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Blood Loss, Surgical

Postoperative Hemorrhage

Study Results

No Results Posted as of Jun 1, 2022