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
• 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

• Blood Coagulation Disorders
• Coagulopathy
• Hemostatic Disorders
• Mesothelioma

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