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Thromboelastography During Surgery for Malignant Pleural Mesothelioma

NCT ID: NCT01912547

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Coagulopathy Mesothelioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood draw for TEG analysis

TEG analysis of blood from patients at different points in time

Blood draw for TEG analysis

Intervention Type PROCEDURE

Blood drawn for TEG analysis

Interventions

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Blood draw for TEG analysis

Blood drawn for TEG analysis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju-Mei Ng

Instructor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ju-Mei Ng, MD

Role: PRINCIPAL_INVESTIGATOR

BWH

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Ju-Mei Ng, MD

Role: primary

Other Identifiers

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2013P000653

Identifier Type: -

Identifier Source: org_study_id