DVT PreventionNCT00338819
ActiveCare+SFT Hemodynamic Profile Compare to SCD Express in Ventilated Patients
An observational study of DVT Prevention and Ventilated Patients, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DVT Prevention, Ventilated Patients
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ventilated patient (Age >18).
- The patient or his guardian is able and voluntarily prepared to sign the Informed Consent Form.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- DVT Prevention, Ventilated Patients
- Keywords
- DVT prevention, Hemodynamic study, IPC, CECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVT PreventionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Sorkine, Prof, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338819
- Sponsor's protocol ID
- TASMC06SP156CTIL
- Status last verified
- Jun 2006
- First submitted
- 18 Jun 2006
- Last updated
- 20 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ActiveCare+SFT Hemodynamic Profile Compare to SCD Express in Ventilated Patients
- ClinicalTrials.gov ID
- NCT00338819
- Acronym / sponsor ID
- TASMC06SP156CTIL
- Conditions
- DVT Prevention, Ventilated Patients
- Keywords
- DVT prevention, Hemodynamic study, IPC, CECT
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult ventilated patient (Age >18).
- The patient or his guardian is able and voluntarily prepared to sign the Informed Consent Form.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sorkine, Prof principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of DVT Prevention and Ventilated Patients, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sorkine, Prof (972-3-6973894, sorkine@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2006.