Postoperative Hemorrhages Clinical Trial
— PREVAILOfficial title:
Prospective Registry on Vascular Access in Interventions in Lazio Region
| Verified date | May 2008 |
| Source | San Filippo Neri General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1052 |
| Est. completion date | June 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - All patients undergoing any percutaneous cardiovascular procedure Exclusion Criteria: - Patients already enrolled in other clinical trials |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| San Filippo Neri General Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke | in-hospital | Yes | |
| Secondary | Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction | in-hospital | Yes |