Mediastinal Temperature and Post-operative Bleeding

Virginia Commonwealth University (VCU)

Status: Withdrawn

Conditions: Blood Loss, Surgical

Treatments: Procedure: Saline irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04933253

HM20021183

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

Procedure: Saline irrigation

Control

No Intervention group

Description:

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