Thromboelastography During Surgery for Malignant Pleural Mesothelioma

NCT01912547 | Unknown DMC

• 1 other identifier: 2013P000653
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulopathy; Mesothelioma

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Blood draw for TEG analysis

TEG analysis of blood from patients at different points in time

Procedure: Blood draw for TEG analysis

Interventions

Blood draw for TEG analysis PROCEDURE

Blood drawn for TEG analysis

Blood draw for TEG analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing surgery for malignant pleural mesothelioma

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders; Mesothelioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ju-Mei Ng, MD

  BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Anaesthesia

Study Record Dates

• First Submitted: July 27, 2013
• First Posted: July 31, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

US (1)