Evaluation of the Coagulation Profile by Thromboelastogra... | NCT01819207

Studies
Evaluation of the Coagulation Profile by Thromboelastography in Bariatric Patients

NCT01819207

Sponsor

Western Galilee Hospital-Nahariya

Status

Completed

Last Update Posted

Jun 1, 2016Estimated

Enrollment

93Actual

Phase

Not Applicable

Conditions

Bariatric Patients Undergoing Bariatric Surgery

Interventions

blood test by thromboelastography

Countries

Israel

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2015Actual

First Submitted Date

Mar 24, 2013

First Submission Date that Met QC Criteria

Mar 26, 2013

First Posted Date

Mar 27, 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

May 31, 2016

Last Update Posted Date

Jun 1, 2016Estimated

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

thromboelastography can identify alteration in the coagulation profile in bariatric patients who undergo sleeve gastrectomy or gastric bypass

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Label	Type	Description	Intervention Names
TEG group	Experimental		Other: blood test by thromboelastography

Name	Type	Description	Arm Group Labels	Other Names
blood test by thromboelastography	Other		TEG group

Measure	Description	Time Frame
coagulation profile by thromboelastography		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing bariatric surgery

Exclusion Criteria:

none

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Naharia Medical Center		Nahariya			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2914257	Background	Munro TG. Glass is detectable on plain radiographs. CMAJ. 1989 Feb 15;140(4):365. No abstract available.