TonsillectomyPhase 4NCT01228136
Tranexamic Acid and Pediatric Adenotonsillectomy
A Phase 4 study testing Tranexamic Acid and normal saline solution in people with Tonsillectomy and Adenoidectomy, run by Irmandade Santa Casa de Misericórdia de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Tonsillectomy, Adenoidectomy, Tranexamic Acid
- What is being tested?
- Tranexamic Acid and normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2010
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with 4 to 12 years
- adenotonsillar hypertrophy
- indication of adenotonsillectomy
Who cannot join
- patients with blood dyscrasia
- patients with history of bleeding of difficult control or spontaneous hematoma
- patients with coagulation tests altered
- patients with evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or auto immune disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital da Criança Santo Antônio
Porto Alegre, Rio Grande do Sul, 90035-074
About this study
Official title: Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.
Read the detailed description
Tonsillectomy with or without adenoidectomy is the most common major surgical procedure performed in children. Although it's a relatively simple procedure, may present complications as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and 1/27.000 in the literature, with approximately 30% due to hemorrhage.
Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic surgery and menorrhagia.
- Conditions
- Tonsillectomy, Adenoidectomy, Tranexamic Acid
- Being tested
- Tranexamic Acid, normal saline solution
- Keywords
- Adenotonsillectomy, Tranexamic acid, Blood loss, Postoperative hemorrhage
- Medical subject headings
- Hemorrhage, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Transamin, Hemoblock
10mg/Kg, IV (in the vein), first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
normal saline solutionOther
normal saline solution in the same volume calculated as treatment (tranexamic acid 250mg/mL, 10mg/Kg), IV (in the vein) first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Active comparator | Not described Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Not described Receives: Other: normal saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of intraoperative bleeding
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
Measured: one day
Secondary outcomes (1)
incidence of postoperative bleeding
incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations
Measured: ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TonsillectomyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Marília R Brum, MD, Principal investigator, Irmandade Santa Casa de Misericórdia de Porto AlegreJosé Faibes Lubianca Neto, MD, Study director, Irmandade Santa Casa de Misericórdia de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228136
- Sponsor's protocol ID
- ISCMPA02
- Status last verified
- Oct 2010
- First submitted
- 22 Oct 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Brum MR, Miura MS, Castro SF, Machado GM, Lima LH, Lubianca Neto JF. Tranexamic acid in adenotonsillectomy in children: a double-blind randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1401-5. doi: 10.1016/j.ijporl.2012.04.028. Epub 2012 Jun 16.
PubMed 22704676
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children
- ClinicalTrials.gov ID
- NCT01228136
- Acronym / sponsor ID
- ISCMPA02
- Conditions
- Tonsillectomy, Adenoidectomy, Tranexamic Acid
- Keywords
- Adenotonsillectomy, Tranexamic acid, Blood loss, Postoperative hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto AlegreUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Oct 2010 (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.
The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.
Detailed description
Tonsillectomy with or without adenoidectomy is the most common major surgical procedure performed in children. Although it's a relatively simple procedure, may present complications as hemorrhage and death. The mortality associated to the surgery range between 1/1.000 and 1/27.000 in the literature, with approximately 30% due to hemorrhage.
Tranexamic acid is an antifibrinolytic hemostatic indicated to control bleeding in cases of hyperfibrinolysis or defective hemostasis diseases. It's major indications are prostatic surgery and menorrhagia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Active comparator | Drug: Tranexamic Acid |
| Placebo | Placebo comparator | Other: normal saline solution |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with 4 to 12 years
- adenotonsillar hypertrophy
- indication of adenotonsillectomy
Key exclusion criteria (4 listed)
- patients with blood dyscrasia
- patients with history of bleeding of difficult control or spontaneous hematoma
- patients with coagulation tests altered
- patients with evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or auto immune disease
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 |
|---|---|---|
| Tranexamic AcidAlso: Transamin, Hemoblock10mg/Kg, IV (in the vein), first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose | Drug | Tranexamic acid |
| normal saline solutionnormal saline solution in the same volume calculated as treatment (tranexamic acid 250mg/mL, 10mg/Kg), IV (in the vein) first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose | Other | Placebo |
Primary outcome
volume of intraoperative bleeding
Time frame: one day
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
1 secondary outcome
incidence of postoperative bleeding
Time frame: ten days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
- Derived from this study: PubMed 22704676Brum MR, Miura MS, Castro SF, Machado GM, Lima LH, Lubianca Neto JF. Tranexamic acid in adenotonsillectomy in children: a double-blind randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1401-5. doi: 10.1016/j.ijporl.2012.04.028. Epub 2012 Jun 16.
Related trials for Tonsillectomy
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Recruiting
Coblator Wand Comparative Analysis
Tonsillectomy, Adenoidectomy
Recruiting
Suprazygomatic Maxillary Nerve Block in Pediatric Tonsillectomy
Tonsillitis
Active, not recruiting
Tonsillectomy Versus Tonsillotomy in the Treatment of Recurrent Acute Tonsillitis
Tonsillitis Recurrent
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.
Marília R Brum, MD principal investigator
Irmandade Santa Casa de Misericórdia de Porto Alegre
José Faibes Lubianca Neto, MD study director
Irmandade Santa Casa de Misericórdia de Porto Alegre
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 Tranexamic Acid and normal saline solution in people with Tonsillectomy and Adenoidectomy, run by Irmandade Santa Casa de Misericórdia de Porto Alegre 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Dec 2010. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
volume of intraoperative bleeding (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228136, which also lists 1 linked publication.
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 22 Dec 2010.