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

U

University Tunis El Manar

Status and phase

Completed
Phase 4

Conditions

Bleeding

Treatments

Drug: Tranexamic acid injection
Drug: SSI

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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