Tranexamic Acid and Pediatric Adenotonsillectomy
Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children
1 other identifier
interventional
95
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 22, 2010
October 1, 2010
10 months
October 22, 2010
December 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
volume of intraoperative bleeding
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
one day
Secondary Outcomes (1)
incidence of postoperative bleeding
ten days
Study Arms (2)
Tranexamic acid
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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 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
Eligibility Criteria
You may qualify if:
- children with 4 to 12 years
- adenotonsillar hypertrophy
- indication of adenotonsillectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital da Criança Santo Antônio
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
Related Publications (1)
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.
PMID: 22704676DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marília R Brum, MD
Irmandade Santa Casa de Misericórdia de Porto Alegre
- STUDY DIRECTOR
José Faibes Lubianca Neto, MD
Irmandade Santa Casa de Misericórdia de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 26, 2010
Study Start
January 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
December 22, 2010
Record last verified: 2010-10