Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

• Status: Completed
• Trial end date: 2015-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Tranexamic Acid

Criteria

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