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NCT Number: NCT02422056

Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty

Randomized study evaluating the role of tranexamic acid in reducing intraoperative bleeding in palatoplasty.

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Key information

Conditions

Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Hemorrhage Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Double-blind randomized study comparing intraoperative bleeding in palatoplasty between patients who received tranexamic acid at a dose of 10mg / kg bolus followed by continuous infusion of 1 mg / kg / h until the end of the procedure and patients receiving placebo in similar arrangements.

Besides the impact on the volume of intraoperative bleeding the incidence of postoperative wound dehiscence in the first week and the incidence of oronasal fistulas after 1 month were evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Palatoplasty indication in patients of any age with presence of congenital cleft palate (with or without associated cleft lip), in the study hospital

Exclusion criteria

  • Preoperative hemoglobin lower than 10 mg / dl or platelet count less than 100,000 / mm3 ;
  • Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions;
  • History of bleeding disorders in first-degree relatives;
  • Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants);
  • Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula;
  • Known allergy to tranexamic acid.

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic acid bolus of 10 mg / kg at the beginning of palatoplasty, followed by infusion of 1 mg / kg / h until the end of the procedure

Other names: Transamin

Saline

Drug

Infusion of saline in the same rate used for the intervention group

Other names: Control

Primary outcomes

  1. intraoperative bleeding

    Time frame: during surgery

    Intraoperative bleeding volume defined as the sum of the volume of aspirated blood during the procedure and the volume of blood retained in the used gauze. The volume retained in the gauze was estimated by the difference between the dry weight and the weight after using them.

Secondary outcomes

  1. Incidence of wound dehiscence

    Time frame: 5 days

    Presence of dehiscence of the surgical wound in partial or total plan of any extension, verified by clinical examination in the first postoperative return and photographic record. The existence of dehiscence was observed by the break in the suture line or extensive presence of fibrin in the wound bed (indicating open area at its base).

  2. Oronasal fistulas

    Time frame: 1 month

    Presence of oronasal fistula type II, III or IV in pittsburgh classification verified on postoperative return at 1 month and photographic record.

  3. incidence of significant bleeding complications

    Time frame: During hospital stay, an expected average of 2 days

    Incidence of bleeding requiring surgical intervention, blood transfusion or use of antifibrinolytic drugs in the postoperative period

Sponsors and collaborators

Lead sponsor

Professor Fernando Figueira Integral Medicine Institute

Other

Registry information

Official study title

Acid Tranexamic Effectiveness in Reducing the Intraoperative Bleeding in Palatoplasty : Randomized Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Apr 21, 2015

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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