Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

Study Overview
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Brief Summary
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Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).

Detailed Description
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78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.

Official Title
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Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)

Conditions
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Bleeding

Intervention / Treatment
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* Drug: tranexamic acid
* Drug: 0.9% NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has laminectomy with instrumentation or equal or more than 3 levels laminectomy age 18-65 years ASA 1-3 elective operation Exclusion Criteria: allergy to tranexamic acid anemia (Hb<12 g/dl in female or Hb<13 g/dl in male) history of CVT, IHD, PE, strokes liver disease chronic kidney disease with creatinie>2.0 mg/dl receive anticoagulant or coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tranexamic acid<br>Tranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose. | Drug: tranexamic acid<br>* Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)<br>* Other names: transamine (Daiichi-Sankyo, Japan);|
| Placebo Comparator: 0.9% NaCl<br>0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose | Drug: 0.9% NaCl<br>* 0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid<br>* Other names: NSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative blood loss | Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative blood transfusion | When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, bleeding, blood transfusion, spine surgery