Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Completed · Phase 4 · Has a placebo group
Conditions studied: Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
In brief
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Key facts
- Study ID
- NCT02063035
- Run by
- Massachusetts General Hospital
- People needed
- 29
- Starts
- 2012-08-01
- Expected to finish
- 2015-04-22
- Last updated by the study team
- 2017-06-08
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-85 years, both male and female
- Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
- Negative pregnancy test
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital Orthopedic Spine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.