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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02063035 |
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Date of registration:
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19/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
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Scientific title:
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Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02063035 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Kirkham B Wood, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-85 years, both male and female
- Undergoing elective multi-level spinal surgery with a posterior approach to the
thoracolumbar spine.
- Negative pregnancy test
Exclusion Criteria:
- Allergy to tranexamic acid
- Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
- Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio
>1.4, or Partial Thromboplastin Time > 1.5 times normal)
- History of deep vein thrombosis, stroke, or pulmonary embolism
- Pregnant or breast feeding
- Liver function tests 2 times the upper limit of normal, and those with creatine
greater than 1.6 milligrams per deciliter (mg/dL)
- Infection
- Revision procedure in which the only procedure is removing instrumentation
- Renal impairment
- Dural tear
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thoracic Spinal Stenosis
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Lumbar Spinal Stenosis
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Intervention(s)
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Drug: Placebo
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Drug: Tranexamic Acid
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Primary Outcome(s)
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Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
[Time Frame: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery]
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Secondary Outcome(s)
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Post-operative Blood Transfusions During Hospitalization
[Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days]
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Blood Loss Volume Following Surgery
[Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days]
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Hospital Length of Stay in Days
[Time Frame: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks]
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Secondary ID(s)
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2012P000266
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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