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Tranexamic Acid and Pediatric Adenotonsillectomy

This study has been completed.
Sponsor:
Information provided by:
Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01228136
First received: October 22, 2010
Last updated: December 21, 2010
Last verified: October 2010

October 22, 2010
December 21, 2010
January 2010
November 2010   (final data collection date for primary outcome measure)
volume of intraoperative bleeding [ Time Frame: one day ] [ Designated as safety issue: No ]
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
Same as current
Complete list of historical versions of study NCT01228136 on ClinicalTrials.gov Archive Site
incidence of postoperative bleeding [ Time Frame: ten days ] [ Designated as safety issue: No ]
incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations
Same as current
Not Provided
Not Provided
 
Tranexamic Acid and Pediatric Adenotonsillectomy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Tonsillectomy
  • Adenoidectomy
  • Tranexamic Acid
  • Drug: 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
    Other Names:
    • Transamin
    • Hemoblock
  • Other: 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
  • Active Comparator: Tranexamic acid
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Placebo
    Intervention: Other: normal saline solution
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
December 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01228136
ISCMPA02
No
Marília Ribeiro Brum, Irmandade Santa Casa de Misericórdia de Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Not Provided
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
Irmandade Santa Casa de Misericórdia de Porto Alegre
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP