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Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01643135
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University

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).

Condition or disease Intervention/treatment Phase
Bleeding Drug: tranexamic acid Drug: 0.9% NaCl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: 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 Name: NSS

Primary Outcome Measures :
  1. perioperative blood loss [ Time Frame: 24 hours ]
    Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage

Secondary Outcome Measures :
  1. perioperative blood transfusion [ Time Frame: 24 hours ]
    When the blood loss more than acceptable and the hematocrit below 30%, the packed red cell will be given.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01643135

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Manee Raksakietisak
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Manee Raksakietisak, MD Mahidol University
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Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University Identifier: NCT01643135    
Other Study ID Numbers: si248/2012
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013
Keywords provided by Manee Raksakietisak, Mahidol University:
tranexamic acid
blood transfusion
spine surgery
Additional relevant MeSH terms:
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Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs