Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Group | Experimental |
| |
| Placebo/ Standard Care group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention with Tranexamic Acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhulikhel Hospital, Kathmandu University Hospital | Dhulikhel | Bagmati | 45200 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28938281 | Result | Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913. | |
| 40763214 | Result | Boucher M, Tremblay J, Pelet T, Dartus J, Belzile EL, Pelet S. Topical Versus Systemic Tranexamic Acid to Reduce Blood Loss After Total Knee and Total Hip Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2025 Oct 15;107(20):2300-2309. doi: 10.2106/JBJS.24.01511. Epub 2025 Aug 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control group (Normal Saline) | Drug | This group receives 50ml of normal saline and is labeled as standard care group. |
|
| 33532495 | Result | Reale D, Andriolo L, Gursoy S, Bozkurt M, Filardo G, Zaffagnini S. Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials. Biomed Res Int. 2021 Jan 16;2021:6961540. doi: 10.1155/2021/6961540. eCollection 2021. |
| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D016063 | Blood Loss, Surgical |
| D005264 | Femoral Fractures |
| D013978 | Tibial Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D007431 | Intraoperative Complications |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D008722 | Methods |
| D014148 | Tranexamic Acid |
| D035061 | Control Groups |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D012107 | Research Design |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided