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)
1 other identifier
interventional
78
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 16, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 18, 2013
December 1, 2013
1.5 years
July 16, 2012
December 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
perioperative blood loss
Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage
24 hours
Secondary Outcomes (1)
perioperative blood transfusion
24 hours
Study Arms (2)
tranexamic acid
ACTIVE COMPARATORTranexamic 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.
0.9% NaCl
PLACEBO COMPARATOR0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose
Interventions
Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
Eligibility Criteria
You may qualify if:
- has laminectomy with instrumentation or equal or more than 3 levels laminectomy
- age 18-65 years
- ASA 1-3
- elective operation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manee Raksakietisak
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manee Raksakietisak, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 16, 2012
First Posted
July 18, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 18, 2013
Record last verified: 2013-12