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
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Bagmati
-
Dhulikhel, Bagmati, Nepal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Tranexamic Acid Group
|
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.
|
|
Placebo-jämförare: Placebo/ Standard Care group
|
This group receives 50ml of normal saline and is labeled as standard care group.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative Blood Loss Measured in Milliliters (mL)
Tidsram: 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.
|
2 years
|
|
Postoperative Blood Loss Measured in Milliliters (mL)
Tidsram: 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.
|
2 years
|
|
Change in Hemoglobin Level Measured in Grams per Deciliter (g/dL)
Tidsram: 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.
|
2 years
|
|
Intraoperative Blood Transfusion Requirement
Tidsram: 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.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse Effects Related to Tranexamic Acid
Tidsram: 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.
|
2 years
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sår och skador
- Postoperativa komplikationer
- Patologiska processer
- Benskador
- Blödning
- Intraoperativa komplikationer
- Patologiska tillstånd, tecken och symtom
- Frakturer, ben
- Lårbensfrakturer
- Tibiafrakturer
- Blodförlust, kirurgiskt
- Postoperativ blödning
- Organiska kemikalier
- Farmaceutiska förberedelser
- Undersökningstekniker
- Epidemiologisk forskningsdesign
- Epidemiologiska metoder
- Forskningsdesign
- Karboxylsyror
- Kristalloidlösningar
- Isotonlösningar
- Lösningar
- Syror, karbocyklisk
- Cyklohexanekarboxylsyror
- Tranexaminsyra
- Metoder
- Kontrollgrupper
- Saltlösning
Andra studie-ID-nummer
- 28/23
Läkemedels- och apparatinformation, studiedokument
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