Lumbar Spinal Stenosis Clinical Trial
Official title:
Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
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.
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.
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