Thromboelastography During Surgery for Malignant Pleural... | NCT01912547

Studies
Thromboelastography During Surgery for Malignant Pleural Mesothelioma

NCT01912547

Sponsor

Brigham and Women's Hospital

Status

Unknown status

Last Update Posted

Jan 30, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Coagulopathy
Mesothelioma

Interventions

Blood draw for TEG analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 27, 2013

First Submission Date that Met QC Criteria

Jul 29, 2013

First Posted Date

Jul 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2015

Last Update Posted Date

Jan 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ju-Mei Ng, Instructor of Anaesthesia, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood draw for TEG analysis		TEG analysis of blood from patients at different points in time	Procedure: Blood draw for TEG analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw for TEG analysis	Procedure	Blood drawn for TEG analysis	Blood draw for TEG analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing surgery for malignant pleural mesothelioma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ju-Mei Ng, MD	BWH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital	Recruiting	Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders
D008654	Mesothelioma

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided