Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients using anticoagulants present an increased risk of bleeding when subjected to oral surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures, may result in thromboembolic events, putting patients health in risk. Recent studies advocate the dental surgery treatment without suspending the anticoagulant therapy, since the values of the international normalized ratio (INR) are in acceptable therapeutic levels and local measurements are taken for the hemostasis control. The aim of this study is to compare the effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated to daily rinses with the drug, with routine post-surgical procedures, to control the post-exodontic bleeding in anticoagulated patients. Patients will be referred by the anticoagulation clinic of the Clementino Fraga Filho University Hospital. Once the study criteria is met patients will be randomly allocated into two groups and subsequently subjected to clinical and periodontal examination, radiographic examination and pre-operative periodontal therapy. Laboratory tests (partial thromboplastic time, prothrombin time, international normalized ratio and platelet count) will be held on the day of the extraction. Patients in group 1 ( EACA ) will receive a paste composed of 01 macerated EACA tablet (500 mg), mixed with 0.9% saline solution in the alveolar socket, and routine post-operative care. Additionally, patients will perform oral rinses three times a day, on the first two post-operative days, with a solution from the macerated EACA 500mg tablet diluted in 2 spoons of filtered water. Patients allocated in group 2 (control) will receive routine post-operative care. Classification of immediate bleeding will be held by the professional, on the day of the surgery, immediately after the suture and twenty minutes later and the delayed bleeding, recorded by the patient through a daily questionnaire. The Statistical Package for the Social Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the database and the Chi-square, Kruskal-Wallis and Mann-Whitney tests will be applied to statistical analysis of the results.The study was approved by the ethical and research committee of the Clementino Fraga Filho University Hospital . All patients will sign a free consent and informed term.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
• Collaborator: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Treatments: Acetaminophen; Aminocaproic Acid; Anticoagulants; Epinephrine; Lidocaine

Criteria

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