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Completed

NCT Number: NCT01228136

Tranexamic Acid and Pediatric Adenotonsillectomy

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

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Key information

Conditions

Tonsillectomy Adenoidectomy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Tranexamic Acid

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital da Criança Santo Antônio

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

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

Other names: Transamin, Hemoblock

normal saline solution

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

Primary outcomes

  1. volume of intraoperative bleeding

    Time frame: one day

    intraoperative bleeding (in mL of aspirated blood) measured at the end of the surgical procedure

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Other

Registry information

Official study title

Use of Tranexamic Acid for Bleeding Reduction in Adenotonsillectomy in Children

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2010
Registry last updated
Dec 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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