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Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643135
First Posted: July 18, 2012
Last Update Posted: December 18, 2013
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.
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University
July 16, 2012
July 18, 2012
December 18, 2013
June 2012
December 2013   (Final data collection date for primary outcome measure)
perioperative blood loss [ Time Frame: 24 hours ]
Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage
Same as current
Complete list of historical versions of study NCT01643135 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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).
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bleeding
  • Drug: tranexamic acid
    Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
    Other Name: transamine (Daiichi-Sankyo, Japan)
  • Drug: 0.9% NaCl
    0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
    Other Name: NSS
  • 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.
    Intervention: Drug: tranexamic acid
  • 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
    Intervention: Drug: 0.9% NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01643135
si248/2012
No
Not Provided
Not Provided
Manee Raksakietisak, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Manee Raksakietisak, MD Mahidol University
Mahidol University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP