An interventional study of Intervention with Tranexamic Acid and Control group (Normal Saline) in Blood Loss, Postoperative, Blood Loss, Surgical and Femoral Fracture, sponsored by Kathmandu University School of Medical Sciences. Completed at 1 site in Nepal. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Kathmandu University School of Medical Sciences · Not applicable, Interventional, and Supportive care
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
144 studies on the registry are indexed under Postoperative Hemorrhage; 28 are open to participants now.
This study's enrollment of 54 is below the median of 100 across 103 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Kathmandu University School of Medical Sciences is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Drug: Intervention with Tranexamic Acid
Drug: Control group (Normal Saline)
In Tranexamic acid (TXA) group, single intravenous dose of Tranexamic Acid (15mg/kg) diluted in 50 ml of normal saline is administered 30 minutes prior to the induction of anesthesia.
This group receives 50ml of normal saline and is labeled as standard care group.
Intraoperative Blood Loss Measured in Milliliters (mL)
Intraoperative blood loss during spine surgery will be measured in milliliters (mL) using suction drain collection and surgical sponge estimation. Lower blood loss indicates better efficacy of tranexamic acid in reducing surgical bleeding.
Time frame: 2 years
Postoperative Blood Loss Measured in Milliliters (mL)
Postoperative blood loss will be assessed in milliliters (mL) from surgical drain output collected during the first 24 hours following surgery. Lower postoperative blood loss indicates better efficacy of tranexamic acid.
Time frame: 2 years
Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)
Reduction in hemoglobin level will be assessed by comparing preoperative and postoperative hemoglobin values measured in grams per deciliter (g/dL). Smaller reduction in hemoglobin indicates lower perioperative blood loss.
Time frame: 2 years
Intraoperative Blood Transfusion Requirement
Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation.
Time frame: 2 years
Adverse Effects Related to Tranexamic Acid
Adverse events related to tranexamic acid administration, including thromboembolic events, allergic reactions, or other drug-related complications, will be recorded during hospital stay and follow-up.
Time frame: 2 years
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Kathmandu University School of Medical Sciences