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

Phase 4

Completed

• Conditions: Bleeding
• Interventions: Drug: Tranexamic acid injection; Drug: SSI

• Registration Number: NCT04224116
• Lead Sponsor: University Tunis El Manar

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2019-10-01
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-02
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
intraoperative bleeding volume	five hours	The blood volume collected in the suction tanks and the operative drapes intraoperatively

Secondary Outcome Measures

Name	Time	Method
bleeding volume in the thoracic drains postoperatively	one month	bleeding volume in the thoracic drains postoperatively every day
The number of red globular caps transfused for each group	one month	transfusion if hemoglobin less than 7 g / dl