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

Bleeding Clinical Trial

— Bleeding  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224116
• Other study ID #: TA
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2014
• Est. completion date: October 2, 2019

Study information

• Verified date: January 2020
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

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.
• SSI
Serum Salin isotonic injected

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative bleeding volume	The blood volume collected in the suction tanks and the operative drapes intraoperatively	five hours
Secondary	The number of red globular caps transfused for each group	transfusion if hemoglobin less than 7 g / dl	one month
Secondary	bleeding volume in the thoracic drains postoperatively	bleeding volume in the thoracic drains postoperatively every day	one month