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出境医 / 临床实验 / Mediastinal Temperature and Post-operative Bleeding

Mediastinal Temperature and Post-operative Bleeding

Study Description
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.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Procedure: Saline irrigation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mediastinal Temperature and Post-operative Bleeding
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental
this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest
 Procedure: Saline irrigation
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
No Intervention: Control
this cohort will receive the normal standard of care as established by the primary surgeon
Outcome Measures
Primary Outcome Measures :
  1. Chest temperature [ Time Frame: At the end of surgery, up to 5 hours ]
    We will use infra-red thermometers to measure the temperature of the chest at the end of surgery

  2. Amount of blood loss [ Time Frame: 24 hours after the end of surgery ]
    amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Arturo Cardounel, M.D. 804-628-2998 arturo.cardounel@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Arturo Cardounel, M.D. Virginia Commonwealth University
Tracking Information
First Submitted Date  ICMJE June 14, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date December 9, 2021
Estimated Study Start Date  ICMJE January 2022
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
  • Chest temperature [ Time Frame: At the end of surgery, up to 5 hours ]
    We will use infra-red thermometers to measure the temperature of the chest at the end of surgery
  • Amount of blood loss [ Time Frame: 24 hours after the end of surgery ]
    amount of blood drained into the cell-saving device or collection canisters from the chest drains that are left in all patients after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mediastinal Temperature and Post-operative Bleeding
Official Title  ICMJE Mediastinal Temperature and Post-operative Bleeding
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Blood Loss, Surgical
Intervention  ICMJE Procedure: Saline irrigation
Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
Study Arms  ICMJE
  • Experimental: Experimental
    this cohort will receive 2 L of warm 37celsius saline irrigation of the mediastinum prior to closure of the chest
    Intervention: Procedure: Saline irrigation
  • No Intervention: Control
    this cohort will receive the normal standard of care as established by the primary surgeon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2021) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2025
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arturo Cardounel, M.D. 804-628-2998 arturo.cardounel@vcuhealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04933253
Other Study ID Numbers  ICMJE HM20021183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arturo Cardounel, M.D. Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP