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Thromboelastography During Surgery for Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01912547
Recruitment Status : Unknown
Verified January 2015 by Ju-Mei Ng, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : July 31, 2013
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
Ju-Mei Ng, Brigham and Women's Hospital

Brief Summary:
Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.

Condition or disease Intervention/treatment
Coagulopathy Mesothelioma Procedure: Blood draw for TEG analysis

Detailed Description:
Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography During Surgery for Malignant Pleural Mesothelioma
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Group/Cohort Intervention/treatment
Blood draw for TEG analysis
TEG analysis of blood from patients at different points in time
Procedure: Blood draw for TEG analysis
Blood drawn for TEG analysis




Primary Outcome Measures :
  1. Coagulation profile during extrapleural pneumonectomy or pleurectomy [ Time Frame: Surgical period (4-6 hours) ]
    Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing surgery for malignant pleural mesothelioma
Criteria

Inclusion Criteria:

  • Adult male or female patients undergoing elective surgery for malignant pleural mesothelioma

Exclusion Criteria:

  • Unwilling or unable to provide consent
  • History of bleeding disorder
  • On medications that may affect hemostasis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912547


Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ju-Mei Ng, MD    617-732-8219    jng1@partners.org   
Principal Investigator: Ju-Mei Ng         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Ju-Mei Ng, MD BWH
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Responsible Party: Ju-Mei Ng, Instructor of Anaesthesia, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01912547    
Other Study ID Numbers: 2013P000653
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial