Reduction Bleeding in Laminectomy With Double Doses of Tranexamic Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University
ClinicalTrials.gov Identifier:
NCT01643135
First received: July 16, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Bleeding
Drug: tranexamic acid
Drug: 0.9% NaCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • perioperative blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage


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


Enrollment: 78
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01643135

Locations
Thailand
Manee Raksakietisak
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Manee Raksakietisak, MD Mahidol University
  More Information

No publications provided

Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01643135     History of Changes
Other Study ID Numbers: si248/2012
Study First Received: July 16, 2012
Last Updated: December 17, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
tranexamic acid
bleeding
blood transfusion
spine surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014