Mediastinal Temperature and Post-operative Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mediastinal Temperature and Post-operative Bleeding

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Procedure: Saline irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest | Procedure: Saline irrigation<br>* Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure<br>|
| No Intervention: Control<br>this cohort will receive the normal standard of care as established by the primary surgeon | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |