Oral HemorrhagePhase 4NCT02238288
Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients
A Phase 4 study testing Aminocaproic acid, Routine dental care and lidocaine and epinephrine in people with Oral Hemorrhage, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Hemorrhage
- What is being tested?
- Aminocaproic acid, Routine dental care and lidocaine and epinephrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clementino Fraga Filho University Hospital
Rio de Janeiro, Rio de Janeiro, 21864-440
About this study
Official title: Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants
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.
Read the 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
- Conditions
- Oral Hemorrhage
- Being tested
- Aminocaproic acid, Routine dental care, lidocaine and epinephrine, Paracetamol
- Keywords
- anticoagulation, extraction, epsilon amino caproic
- Medical subject headings
- Oral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminocaproic acidDrug
Also called Ipsilon©
Crushed tablet in the dental socket
Routine dental careOther
Also called Routine procedures after dental extractions
Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
lidocaine and epinephrineDrug
2%
ParacetamolDrug
750 mg
| Study group | Role | What they receive |
|---|---|---|
| aminocaproic acid | Active comparator | Crushed tablets inserted in the dental socket post-extraction Receives: 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 Receives: Other: Routine dental care; Drug: lidocaine and epinephrine; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-Hematologia
- Sponsor type
- Research network
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238288
- Sponsor's protocol ID
- AEAC2014
- Status last verified
- Sep 2014
- First submitted
- 10 Sep 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants
- ClinicalTrials.gov ID
- NCT02238288
- Acronym / sponsor ID
- AEAC2014
- Conditions
- Oral Hemorrhage
- Keywords
- anticoagulation, extraction, epsilon amino caproic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Grupo de Estudos Multicentricos em Onco-HematologiaResearch network
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aminocaproic acid | Active comparator | Drug: Aminocaproic acid, Drug: lidocaine and epinephrine, Drug: ParacetamolCrushed tablets inserted in the dental socket post-extraction |
| Routine care after dental extraction | Other | Other: Routine dental care, Drug: lidocaine and epinephrine, Drug: ParacetamolChompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminocaproic acidAlso: Ipsilon©Crushed tablet in the dental socket | Drug | aminocaproic acid |
| Routine dental careAlso: Routine procedures after dental extractionsChompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes | Other | Routine care after dental extraction |
| lidocaine and epinephrine2% | Drug | Routine care after dental extraction, aminocaproic acid |
| Paracetamol750 mg | Drug | Routine care after dental extraction, aminocaproic acid |
Primary outcome
bleeding post-exodontic
Time frame: up to twenty minutes
* No bleeding * Bleeding Light - blood in saliva * Moderate Bleeding - bleeding controlled with local measures * Severe Bleeding - when required surgical intervention and / or hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aminocaproic acid, Routine dental care and lidocaine and epinephrine in people with Oral Hemorrhage, run by Grupo de Estudos Multicentricos em Onco-Hematologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding post-exodontic (time frame: up to twenty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.