Prophylaxis of Deep Vein ThrombosisNCT00713973
Comparative Study Between Thrombosis Prophylaxis Protocols
An observational study of Prophylaxis of Deep Vein Thrombosis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis of Deep Vein Thrombosis
- How many people
- 212 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Jun 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year.
Who may be able to join
- Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year
Who cannot join
- refusal to participate in the research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between American and Brazilian Protocols for Deep Venous Thrombosis Prophylaxis: a New Proposal
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.
Read the detailed description
Not desired
- Conditions
- Prophylaxis of Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJun 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylaxis of Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- JORGE L MOULIM, Principal investigator, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713973
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-09
- Status last verified
- Jul 2008
- First submitted
- 8 Jul 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between American and Brazilian Protocols for Deep Venous Thrombosis Prophylaxis: a New Proposal
- ClinicalTrials.gov ID
- NCT00713973
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-09
- Conditions
- Prophylaxis of Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Jul 2008 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year.
Key inclusion criteria (1 listed)
- Patients who underwent plastic surgery in the Hospital of the Medical School of Botucatu, in the period of one year
Key exclusion criteria (1 listed)
- refusal to participate in the research protocol
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
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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.
JORGE L MOULIM principal investigator
UPECLIN HC FM Botucatu Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prophylaxis of Deep Vein Thrombosis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 Oct 2008.