Mediastinal Temperature and Post-operative Bleeding

Virginia Commonwealth University

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Blood Loss, Surgical

Interventions

Saline irrigationPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Chest temperature

We will use infra-red thermometers to measure the temperature of the chest at the end of surgery

Time frame: 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

Time frame: 24 hours after the end of surgery

Data from ClinicalTrials.gov

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