ActiveCare+SFT Hemodynamic Profile Compare to SCD Express... | NCT00338819

Studies
ActiveCare+SFT Hemodynamic Profile Compare to SCD Express in Ventilated Patients

NCT00338819

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jun 20, 2006Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

DVT Prevention
Ventilated Patients

Interventions

Not provided

Countries

Not provided

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

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 18, 2006

First Submission Date that Met QC Criteria

Jun 18, 2006

First Posted Date

Jun 20, 2006Estimated

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

Jun 18, 2006

Last Update Posted Date

Jun 20, 2006Estimated

Description Module

Brief Summary

Purpose:

To test the hemodynamic profile generated by the MCS's ActiveCare+SFT device in ventilated patients and compare it to that of the Kendall SCD Express.

Design:

Comparative, prospective study. Patients are their own controls.

Detailed Description

Not provided

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

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult ventilated patient (Age >18).
The patient or his guardian is able and voluntarily prepared to sign the Informed Consent Form.

Exclusion Criteria:

Known, preexisting DVT or PE.
Patient who is participating in another clinical trial.
Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.

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

Name	Role	Phone	Extension	Email
Sorkine, Prof	Contact	972-3-6973894		sorkine@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Sorkine, Prof	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Not provided