Tranexamic Acid and Pediatric Adenotonsillectomy

December 21, 2010 updated by: Irmandade Santa Casa de Misericórdia de Porto Alegre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Hospital da Criança Santo Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of intraoperative bleeding
Time Frame: one day
intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of postoperative bleeding
Time Frame: ten days
incidence of oral bleeding at the ten days after surgery, evaluated by a patient's diary and postoperative medical evaluations
ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Principal Investigator: Marília R Brum, MD, Irmandade Santa Casa de Misericordia de Porto Alegre
  • Study Director: José Faibes Lubianca Neto, MD, Irmandade Santa Casa de Misericordia de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 21, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCMPA02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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