Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

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)

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).

Study Overview

• Status: Completed
• Conditions: Bleeding
• Intervention / Treatment: Drug: tranexamic acid; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Manee Raksakietisak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tranexamic acid; 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; Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo); Other Names: transamine (Daiichi-Sankyo, Japan)
Placebo Comparator: 0.9% NaCl; 0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose	Drug: 0.9% NaCl; 0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid; Other Names: NSS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 17, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: bleeding; blood transfusion; tranexamic acid; spine surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Fibrin Modulating Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Anti-Anxiety Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Monoamine Oxidase Inhibitors; Tranexamic Acid; Tranylcypromine
• Other Study ID Numbers: si248/2012