Comparative Study Between Thrombosis Prophylaxis Protocols | NCT00713973

Studies
Comparative Study Between Thrombosis Prophylaxis Protocols

NCT00713973

Sponsor

UPECLIN HC FM Botucatu Unesp

Status

Completed

Last Update Posted

Oct 20, 2008Estimated

Enrollment

212Actual

Phase

Not provided

Conditions

Prophylaxis of Deep Vein Thrombosis

Interventions

Not provided

Countries

Brazil

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

Jul 2008

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

Jun 2007

Primary Completion Date

Not provided

Completion Date

Jun 2008Actual

First Submitted Date

Jul 8, 2008

First Submission Date that Met QC Criteria

Jul 8, 2008

First Posted Date

Jul 14, 2008Estimated

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

Oct 17, 2008

Last Update Posted Date

Oct 20, 2008Estimated

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

Background: Compare the American and Brazilian protocols for prophylaxis of deep vein thrombosis (DVT), seeking to draft a new protocol, more comprehensive and applicable. Methods: A prospective study was conducted over a year, covering 212 patients, comparing the protocols on the stratification of risk of DVT, and the type of prophylaxis indicated. A new protocol was proposed, applied and compared to previous.

Detailed Description

Not desired

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

212Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Submitted to the American protocol for prophylaxis of deep vein thrombosis
2		Submitted to the Brazilian protocol for prophylaxis of deep vein thrombosis
3		Submitted to the SBCP modified protocol for prophylaxis of deep vein thrombosis

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year

Exclusion Criteria:

refusal to participate in the research protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JORGE L MOULIM	UPECLIN HC FM Botucatu Unesp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of UNESP		Botucatu	São Paulo	18.618-970	Brazil