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

NCT02238288 | Unknown Phase 4

• 1 other identifier: AEAC2014
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Hemorrhage

Keywords

anticoagulation; extraction; epsilon amino caproic

Outcome Measures

Primary Outcomes (1)

• bleeding post-exodontic

  * No bleeding * Bleeding Light - blood in saliva * Moderate Bleeding - bleeding controlled with local measures * Severe Bleeding - when required surgical intervention and / or hospitalization

  up to twenty minutes

Study Arms (2)

aminocaproic acid

ACTIVE COMPARATOR

Crushed tablets inserted in the dental socket post-extraction

Drug: Aminocaproic acid; Drug: lidocaine and epinephrine; Drug: Paracetamol

Routine care after dental extraction

OTHER

Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes

Other: Routine dental care; Drug: lidocaine and epinephrine; Drug: Paracetamol

Interventions

Routine dental care OTHER

Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes

Also known as: Routine procedures after dental extractions

Routine care after dental extraction

lidocaine and epinephrine DRUG

2%

Routine care after dental extraction; aminocaproic acid

Paracetamol DRUG

750 mg

Routine care after dental extraction; aminocaproic acid

Aminocaproic acid DRUG

Crushed tablet in the dental socket

Also known as: Ipsilon©

aminocaproic acid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo de Estudos Multicentricos em Onco-Hematologia: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, 21864-440, Brazil

Location

MeSH Terms

Conditions

Oral Hemorrhage

Interventions

Aminocaproic Acid; Lidocaine; Epinephrine; Acetaminophen

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Oral Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

BR (1)