- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02238288
Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients
Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients will be submitted to clinical and radiographic examination. Once selected, patients will receive hygiene instruction and will be submitted to full mouth scaling one week before the procedure with an ultrasonic device (CavitronR - Dentsply). The random allocation of patients will obey the order obtained in the computerized program Allocation 1.0 Software© (Isfahan, Iran, 2004). All patients should have the prothrombin time (PT) and INR, active thromboplastin partial time (aTPT) and platelet counts tests on the day of surgery. Patients who present INR< 2.0 e > 4 will be assessed by the medical team about the possibility of change in the dose of medication to the surgical procedure. Patients with predisposing heart conditions the bacterial endocarditis will receive antibiotic prophylaxis as recommendations from American Association of Cardiology (AHA) of 2007. All extraction procedures will be performed by non-traumatic conventional surgical techniques, under local anesthesia (2% lidocaine and epinephrine 1: 100,000). Just one extraction will be performed in each surgical procedure, by the same surgeon. All patients will receive digital compression of socket with sterile gauze for 5 minutes (Chompret 's manoeuver) and suture with non-resorbable wire, silk 3.0 type . Everyone will receive the base analgesic prescription Paracetamol 750 mg (Tylenol© - Johnson & Johnson), 01 tablet every 6 hours, by oral administration, for control of postoperative pain. Patients are divided into two groups:
Group 1 (EACA) - patients will receive the intra-alveolar application of a 500 mg tablet of the epsilon-amino caproic acid (EACA - Ipsilon® - Nikko Brazil, RJ) crushed in 0.9% saline. Additionally, they will be instructed to rinse with 500mg EACA tablets macerated and diluted in 2 tablespoons of water three times a day, in the two days after the extraction.
Group 2 (control) - patients will receive routine postoperative care.
Classification of Bleeding will be performed by the professional on the day of surgery at two times: one time (immediately after extraction) and time 2 (after 20 minutes). The bleeding will be classified as follows:
- No bleeding
- Light bleeding - blood in saliva
- Moderate Bleeding - bleeding controlled with local measures
- Severe Bleeding - when surgical intervention is required
Late bleeding will be recorded by the patient through daily questionnaire. The bleeding will be classified as follows:
- No bleeding
- Blood stained saliva
- Bleeding that stopped after compression bandage and ice pack for 20 minutes
- Bleeding stopped only after professional intervention
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 21864-440
- Clementino Fraga Filho University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: aminocaproic acid
Crushed tablets inserted in the dental socket post-extraction
|
Crushed tablet in the dental socket
Other Names:
2%
750 mg
|
Other: Routine care after dental extraction
Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
|
2%
750 mg
Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bleeding post-exodontic
Time Frame: up to twenty minutes
|
|
up to twenty minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Stomatognathic Diseases
- Mouth Diseases
- Oral Manifestations
- Hemorrhage
- Oral Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Fibrin Modulating Agents
- Antipyretics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Acetaminophen
- Epinephrine
- Aminocaproic Acid
Other Study ID Numbers
- AEAC2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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