Clinical trial NCT04224116: Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery
Official title: Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Keywords: tranexamic acid
Antifibrinolytic agents
bleeding
blood transfusion
thoracic surgery.
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: intraoperative bleeding volume
timeFrame: five hours
Secondary outcomes:
measure: The number of red globular caps transfused for each group
timeFrame: one month
measure: bleeding volume in the thoracic drains postoperatively
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: university Manar Tunis
name: Tahar Mestiri, Professor
role: PRINCIPAL_INVESTIGATOR
References: