Skip to content

Mediastinal Temperature and Post-operative Bleeding

Mediastinal Temperature and Post-operative Bleeding

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04933253
Enrollment
0
Registered
2021-06-21
Start date
2022-10-31
Completion date
2025-08-31
Last updated
2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical

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.

Interventions

Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chest temperatureAt the end of surgery, up to 5 hoursWe will use infra-red thermometers to measure the temperature of the chest at the end of surgery
Amount of blood loss24 hours after the end of surgeryamount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026