Clinical trial NCT01643135: Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Keywords: tranexamic acid
bleeding
blood transfusion
spine surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: perioperative blood loss
timeFrame: 24 hours
Secondary outcomes:
measure: perioperative blood transfusion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Manee Raksakietisak
Study officials:
affiliation: Mahidol University
name: Manee Raksakietisak, MD
role: PRINCIPAL_INVESTIGATOR
References: