heart disease, oral bleeding, anticoagulants
Conditions
Interventions
The sample calculation was based on clinical trial of superiority for binary outcome. Sealed Envelope Ltd. 2012. (www.sealedenvelope.com/power/binary-superiority) was calculated, with a significance l
Drug
E06.892
Sponsors
Universidade Federal de Sergipe
Universidade Federal de Sergipe
Eligibility
Inclusion criteria
Inclusion criteria: Patients taking oral anticoagulants for at least 14 days; patients with indication of small oral surgeries; patients with INR (International Normalized Norm) between 1.5 and 4.0 the day before the procedure.
Exclusion criteria
Exclusion criteria: Patients with blood dyscrasia or other conditions that alter blood clotting; patients smokers; diabetic patients; pregnant or lactating patients; patients with a history of allergy to tranexamic acid or reabsorbable collagen gelatin; patients using medications that may interact with medications used in this study; oral surgeries that last 40 minutes; oral surgeries with large osteotomies (third molars included and impacted); patients with INR above 3.5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There will be evaluated 03 outcomes: Expected outcome 1: Intraoral postoperative bleeding will be observed at the site of uncontrolled dental extraction (ie, after 30 min. Gauze compression, active bleeding at the operated site), absolute numbers ( per site operated). The estimated relative risk for post-operative bleeding episodes with 95% confidence intervals will be calculated. The outcome will be assessed by visual inspection of the operated site, observing bleeding, the first in the immediate postoperative period by 02 hours and after 07 postoperative days. In the period between the return will be considered bleeding if after biting gauze for 20 minutes and observe, the patient reports that the same case does not stop. Bleeding from the surgical wound will be classified according to Souto et al. (1996): a. Mild bleeding: Bleeding that stopped spontaneously or with local compression with gauze for 20 minutes. B. Severe bleeding: bleeding that did not stop with the previous measures and that demanded a new intervention on the part of the researcher. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: presence of thromboembolic events. The estimated relative risk for episodes of thromboembolic events with 95% confidence intervals will be calculated. The evaluation of the expected outcome 2 will be performed by measuring the possible presence of thromboembolic events such as signs and symptoms of myocardial infarction, deep vein thrombosis and pulmonary embolism in the postoperative period of 07 days. All the patients in the research are assisted by the cardiologist weekly and are released directly for the accomplishment of the precedence.;Expected outcome 3: increased postoperative RNI (International Normalized Ratio) values. The evaluation of the expected outcome 3 will be done by requesting blood clotting laboratory tests, and recording RNI (values of therapeutic standards between 1.5 and 3.5) in the postoperative period of 07 days. Above 3.5 increases the probability of bleeding at the surgical site of difficult control with local hemostasis. The INR values of the postoperative laboratory tests will be compared by means of the t-test for independent samples or Mann-Whitney U test, depending of the data distribution. The level of significance adopted will be 5%. | — |
Countries
Brazil
Contacts
Public ContactSara Juliana Vasconcellos
Universidade Federal de Sergipe
Outcome results
None listed