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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02238288 |
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Date of registration:
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10/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients
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Scientific title:
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Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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154 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT02238288 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients over 18 years of age, use of warfarin sodium with or without anti-platelet
aggregation, indicating simple extractions whose INR values ??are between 2.0 and 4.0
and that consent to participate in the study.
Exclusion Criteria:
- Patients with platelet count < 50,000 / mm3 Pregnant women or lactating Patients with
hypersensitivity to the components of EACA. Patients with coagulopathies Patients who
have impacted teeth, ankylosed or root morphological alterations that may complicate
the procedure Patients who fail to submit laboratory and radiographic examinations
necessary for the surgery
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Oral Hemorrhage
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Intervention(s)
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Drug: Paracetamol
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Drug: lidocaine and epinephrine
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Other: Routine dental care
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Drug: Aminocaproic acid
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Primary Outcome(s)
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bleeding post-exodontic
[Time Frame: up to twenty minutes]
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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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