Blood Loss, Postoperative, Blood Loss, Surgical, Femoral Fracture, Tibial Fracture
Conditions
Keywords
Femur, Fracture, Intramedullary Nailing, Surgical blood loss, Tibia, Tranexamic acid
Brief summary
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
Interventions
DRUGIntervention with Tranexamic Acid
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.
DRUGControl group (Normal Saline)
This group receives 50ml of normal saline and is labeled as standard care group.
Sponsors
Kathmandu University School of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss Measured in Milliliters (mL) | 2 years | 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. |
| Postoperative Blood Loss Measured in Milliliters (mL) | 2 years | 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. |
| Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL) | 2 years | 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. |
| Intraoperative Blood Transfusion Requirement | 2 years | Blood transfusion requirement during surgery will be measured as the number of blood units transfused intraoperatively. Lower transfusion requirement indicates better blood conservation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects Related to Tranexamic Acid | 2 years | 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. |
Countries
Nepal
Outcome results
None listed