Main
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Note: This record shows only 22 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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02243839 |
Date of registration:
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12/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis
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Scientific title:
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Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study |
Date of first enrolment:
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January 2014 |
Target sample size:
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100 |
Recruitment status: |
Recruiting |
URL:
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http://clinicaltrials.gov/show/NCT02243839 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Mehmet Özkan, Prof |
Address:
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Telephone:
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905322551512 |
Email:
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memoozkan1@gmail.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Obstructive prosthetic valve thrombosis
Exclusion Criteria:
- Non-obstructive prosthetic valve thrombosis
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Thrombus
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Intervention(s)
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Procedure: Surgery
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Drug: Thrombolytic Therapy
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Primary Outcome(s)
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Complications for surgery
[Time Frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month]
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In hospital mortality
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]
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Successful Surgery
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months]
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Thrombolytic success
[Time Frame: Up to 10 days]
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Non-fatal complications for thrombolytic therapy
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]
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Secondary ID(s)
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KOSUYOLU3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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