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
  Purpose

The purpose of this study is to determine if the use of tranexamic acid prior adenotonsillectomy in children can reduce surgical and postoperative bleeding.


Condition Intervention Phase
Tonsillectomy
Adenoidectomy
Tranexamic Acid
Drug: Tranexamic Acid
Other: normal saline solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

Resource links provided by NLM:


Further study details as provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 95
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Placebo Comparator: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228136

Locations
Brazil
Hospital da Criança Santo Antônio
Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
Sponsors and Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
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
  More Information

No publications provided by Irmandade Santa Casa de Misericórdia de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marília Ribeiro Brum, Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier: NCT01228136     History of Changes
Other Study ID Numbers: ISCMPA02
Study First Received: October 22, 2010
Last Updated: December 21, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:
Adenotonsillectomy
Tranexamic acid
Blood loss
Postoperative hemorrhage

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014