Mediastinal Temperature and Post-operative Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2025-08-31

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.

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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.

Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental

this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest

Group Type EXPERIMENTAL

Saline irrigation

Intervention Type PROCEDURE

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

Control

this cohort will receive the normal standard of care as established by the primary surgeon

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Saline irrigation

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No