Bleeding
Conditions
Keywords
tranexamic acid, Antifibrinolytic agents, bleeding, blood transfusion, thoracic surgery.
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.
Interventions
DRUGTranexamic 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.
DRUGSSI
Serum Salin isotonic injected
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double blind investigation
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative bleeding volume | five hours | The blood volume collected in the suction tanks and the operative drapes intraoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of red globular caps transfused for each group | one month | transfusion if hemoglobin less than 7 g / dl |
| bleeding volume in the thoracic drains postoperatively | one month | bleeding volume in the thoracic drains postoperatively every day |
Outcome results
None listed