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

Overview

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.

Full Title of Study: “Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: October 2, 2019

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.

Interventions

• Drug: Tranexamic acid injection
  • to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
• Drug: SSI
  • Serum Salin isotonic injected

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

• intraoperative bleeding volume
  • Time Frame: five hours
  • The blood volume collected in the suction tanks and the operative drapes intraoperatively

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University Tunis El Manar
• Provider of Information About this Clinical Study
  • Principal Investigator: Amani Ben Haj Youssef, Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Pulmonary Resection Surgery – University Tunis El Manar
• Overall Official(s)
  • Tahar Mestiri, Professor, Principal Investigator, university Manar Tunis