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NCT01912547 Clinical Trial

Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Mesothelioma Clinical Trial

Official title:
Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01912547
Other study ID # 2013P000653
Secondary ID
Status Recruiting
Phase Phase 0
First received July 27, 2013
Last updated January 28, 2015
Start date September 2013
Est. completion date December 2015

Study information
Verified date January 2015
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood draw for TEG analysis
Blood drawn for TEG analysis

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coagulation profile during extrapleural pneumonectomy or pleurectomy Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery Surgical period (4-6 hours) No
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