EFFECT OF TRANEXAMIC ACID ON PERIOPERATIVE BLOOD LOSS IN REAMED INTRAMEDULLARY NAILING OF DIAPHYSEAL FEMORAL AND TIBIAL FRACTURES: A PROSPECTIVE COMPARATIVE STUDY

Effect of Tranexamic Acid on Perioperative Blood Loss in Reamed Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures: A Prospective Comparative Study.

Perioperative blood loss is one of the most frequently encountered and significant complications of spine surgery. Intraoperative and post-operative bleeding cause various complications and negatively affect patient outcomes. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Intravenous administration of transxamic acid appears to reduce perioperative damage and the need for blood transfusions in spine surgery. The study is done in patients admitted to Dhulikhel Hospital undergoing elective open spine surgery, to study the efficacy of tranexamic acid in reducing blood loss and need of blood transfusion in patients undergoing spine surgery. Patients undergoing spine surgeries are enrolled and allocated by computer generated randomization into 2 groups, (a) placebo group, receiving 0.9% NaCl, (b) tranexamic acid group, receiving 2 doses of tranexamic acid(15mg/kg). Intraoperative and post-operative blood loss are measured. Study parameters include estimated blood loss, hemoglobin, hematocrit and number of blood transfusions required in post-operative setting. Study parameters are compared across two groups using appropriate statistical tools. This study will help us determine the role of tranexamic acid in reducing perioperative blood loss and need for blood transfusion in patients undergoing spine surgery.

HYPOTHESES OF THE STUDY:

Null hypothesis (H0): There is no significant effect of tranexamic acid in reduction of blood loss compared to study group Alternate hypothesis (H1): There is significant improved effect of tranexamic acid in reduction of blood loss.

Hence, H0 : Mean of Parameters of Control groups >= mean of parameters of Study groups.

H1: Mean of parameters of Control groups < Mean of parameters of Study groups

Inclusion Criteria:

• Patients aged 16-60 years
• Patients with isolated diaphyseal fracture (Shaft fracture of femur or Shaft fracture of tibia)
• Patients planned for reamed intramedullary nailing
• Patients willing to provide informed consent

Exclusion Criteria:

• Patients with polytrauma
• Fractures requiring open reduction
• Gustilo-Anderson Grade III open fractures
• Known history of coagulopathy
• International Normalized Ratio (INR) > 1.2
• Current use of anticoagulant therapy
• Current use of antiplatelet therapy
• Presence of major hepatic failure
• Presence of major renal failure
• Patients unwilling or unable to provide informed consent