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Tranexamic Acid and Pediatric Adenotonsillectomy

NCT ID: NCT01228136

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Tonsillectomy Adenoidectomy Tranexamic Acid

Keywords

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Adenotonsillectomy Tranexamic acid Blood loss Postoperative hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

normal saline solution

Intervention Type OTHER

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

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

normal saline solution

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

Intervention Type OTHER

Other Intervention Names

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Transamin Hemoblock

Eligibility Criteria

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Inclusion Criteria

* children with 4 to 12 years
* adenotonsillar hypertrophy
* indication of adenotonsillectomy

Exclusion Criteria

* 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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Irmandade Santa Casa de Misericórdia de Porto Alegre

Principal Investigators

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Marília R Brum, MD

Role: PRINCIPAL_INVESTIGATOR

Irmandade Santa Casa de Misericórdia de Porto Alegre

José Faibes Lubianca Neto, MD

Role: STUDY_DIRECTOR

Irmandade Santa Casa de Misericórdia de Porto Alegre

Locations

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Hospital da Criança Santo Antônio

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22704676 (View on PubMed)

Other Identifiers

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ISCMPA02

Identifier Type: -

Identifier Source: org_study_id