Postoperative HemorrhagesPhase 4PREVAILNCT00674778
Prospective Registry on Vascular Access in Interventions in Lazio Region
A Phase 4 study testing Any percutaneous cardiovascular procedure in people with Postoperative Hemorrhages, run by San Filippo Neri General Hospital.
Trial summary
Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Hemorrhages
- What is being tested?
- Any percutaneous cardiovascular procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,052 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jun 2006
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing any percutaneous cardiovascular procedure
Who cannot join
- Patients already enrolled in other clinical trials
About this study
Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.
We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.
- Conditions
- Postoperative Hemorrhages
- Being tested
- Any percutaneous cardiovascular procedure
- Keywords
- Radial, Femoral, artery, Invasive cardiology safety
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any percutaneous cardiovascular procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radial approach Receives: Procedure: Any percutaneous cardiovascular procedure |
| 2 | Active comparator | Femoral approach Receives: Procedure: Any percutaneous cardiovascular procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
Measured: in-hospital
Secondary outcomes (1)
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
Measured: in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhagesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Richichi, MD, Study chair, San Filippo Neri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674778
- Sponsor's protocol ID
- 1/6/2006
- Acronym
- PREVAIL
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 8 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry on Vascular Access in Interventions in Lazio Region
- ClinicalTrials.gov ID
- NCT00674778
- Acronym / sponsor ID
- PREVAIL / 1/6/2006
- Conditions
- Postoperative Hemorrhages
- Keywords
- Radial, Femoral, artery, Invasive cardiology safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,052 participants (actual)
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Jun 2006
- First posted
- 8 May 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.
Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.
We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Any percutaneous cardiovascular procedureRadial approach |
| 2 | Active comparator | Procedure: Any percutaneous cardiovascular procedureFemoral approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing any percutaneous cardiovascular procedure
Key exclusion criteria (1 listed)
- Patients already enrolled in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any percutaneous cardiovascular procedure | Procedure or surgery | 1, 2 |
Primary outcome
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
Time frame: in-hospital
1 secondary outcome
Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
Time frame: in-hospital
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 8 May 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.
Giuseppe Richichi, MD study chair
San Filippo Neri Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Any percutaneous cardiovascular procedure in people with Postoperative Hemorrhages, run by San Filippo Neri General Hospital.
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 8 May 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke (time frame: in-hospital). It is what the study was designed to measure, not a finding.
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 8 May 2008.