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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bleeding

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Drug: SSI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group TA<br>receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. | Drug: Tranexamic acid injection<br>* to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.<br>* Other names: EXACYL;|
| Placebo Comparator: Group SSI<br>Serum saline isotonic (SSI) group: placebo with isotonic saline serum. | Drug: SSI<br>* Serum Salin isotonic injected<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative bleeding volume | The blood volume collected in the suction tanks and the operative drapes intraoperatively | five hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.