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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00716365 |
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Date of registration:
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22/05/2008 |
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Primary sponsor: |
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Public title:
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USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures
USF-Hemostasis |
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Scientific title:
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USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00716365 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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Israel
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Contacts
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Name:
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Morris Mosseri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tel-Aviv University, Sackler School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-80 years old
- Signing an informed consent
- Percutaneous coronary angiography with a 6 french sheath via the femoral artery
- Post catheterization non-invasive systolic blood pressure 150 mm Hg
Exclusion criteria:
- STEMI
- Patients who received IIb-IIIa antagonists before or during angiography.
- Patients who received more than 2500u IV Heparin or more than 0.5 mg/kg LMWH within 8
hours before the procedure.
- Known bleeding tendency, disturbed clotting system or platelet function
- Evidence of bleeding or hematoma at the access site prior to sheath removal.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Angiography
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Intervention(s)
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Device: HemCon bandage
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Primary Outcome(s)
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Primary efficacy endpoint will be time to hemostasis.
[Time Frame: 1 hour]
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Secondary Outcome(s)
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be safety (complication rate) and satisfaction of patients regarding time to sitting incline and time to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the femoral artery at the access site.
[Time Frame: 24 hours]
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Secondary ID(s)
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0152-07MMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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