Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Condition: Lumbar Spinal Stenosis; Thoracic Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Tranexamic acid, an antifibrinolytic agent, has been studied at great length across a myriad
      of medical specialties to reduce blood lost during these surgeries. Topical tranexamic acid
      administration reduces postoperative blood loss and proved safe in multiple types of
      surgeries -e.g. cardiothoracic, oral and maxillofacial, eye, ear and throat.(References:
      Fawzy and others [et al], Wong et al, Zufferey et al, Wang et al, Ipema et al).

      Intravenous tranexamic acid administration has been shown to reduce postoperative blood loss
      and transfusion need in patients undergoing spinal surgery (Reference: Elwatidy et al). Some
      advocates have suggested that topical (i.e. local) administration might be preferred over
      intravenous application. Topical administration of tranexamic acid has some potential
      advantages as it leads to lower systemic absorption, and offers less concern over the risk of
      thromboembolic complications (References: Wong et al, Raveendran et al).

      While systemic (intravenous) use of tranexamic acid has been studied in spine surgery, there
      has been little studied to show its effectiveness at reducing blood loss when used topically.

      This study proposes to determine if the topical application of tranexamic acid into the
      surgical wound of posterior multi-level lumbar spine surgery will decrease postoperative
      blood loss, thus decreasing the need for potential transfusions. Tranexamic acid has been
      well documented for its safety and efficacy, the investigators believe that this agent will
      become an important tool to reduce the blood loss in spinal surgeries. It offers a reduction
      in blood loss and, ultimately, a decrease in the transfusion rates which pose risks to the
      subject and significant cost.
    

Intervention name(s): Tranexamic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.; A single topical application of matching placebo, which is 100 mL of normal saline.
Other intervention name(s): Cyklokapron®
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: lumbar spine surgery; thoracic spine surgery