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Completed

NCT Number: NCT04224116

Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery

Bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs.

The objective of this study is to evaluate the efficiency of tranexamic acid (TA) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

It's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. Demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified.

Two groups of patients:

  • TA group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
  • Serum saline isotonic (SSI) group: placebo with isotonic saline serum.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux.

Exclusion criteria

  • Patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.

Treatment and study plan

Tranexamic acid injection

Drug

to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.

Other names: EXACYL

SSI

Drug

Serum Salin isotonic injected

Other names: placebo

Primary outcomes

  1. intraoperative bleeding volume

    Time frame: five hours

    The blood volume collected in the suction tanks and the operative drapes intraoperatively

Secondary outcomes

  1. The number of red globular caps transfused for each group

    Time frame: one month

    transfusion if hemoglobin less than 7 g / dl

  2. bleeding volume in the thoracic drains postoperatively

    Time frame: one month

    bleeding volume in the thoracic drains postoperatively every day

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery

Acronym: Bleeding

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

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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