None listed
Conditions
Brief summary
The purpose of the study will be to determine the effect of a single bolus dose of tranexamic acid, given intravenously at the beginning of the operation, on blood loss and need for blood transfusions in hip fracture surgery. Patients of intertrochanteric fractures undergoing DHS surgery will be divided into Two groups A(tranexamic acid) and group B(Placebo) and will receive 1 g of intravenous TXA mixed in 100 cc of saline, and an equivalent volume bolus of saline respectively at the time of surgical incision. Blood loss will be estimated based on the hemoglobin drop by measuring hemoglobin on consecutive measures, preoperative in the morning before surgery, 6 hours postoperative , 24 hours postoperative.,48 hours and 72 hours. The primary outcome of the study will be the rate of blood transfusion from the time of surgery until discharge at 72 hours post operatively. The secondary study outcomes include ,re operation and frequency of adverse events at 6 months follow up (including transfusion reaction, myocardial infarction, symptomatic DVT, pulmonary embolus, reoperation, readmission, wound infection and death) Our hypothesis is that the administration of Tranexamic acid (TXA) will decrease blood loss in hip fracture patients and lower the rate of allogenic blood transfusion.
Interventions
Brief Name:Tranexamic Acid(TXA) usage in hip fracture surgery
1 gram of intravenous Tranexamic acid(TXA) mixed in 100 cc of saline, bolused at the time of surgical incision in operation theatre to patients with dynamic hip screw fixation for intertrochanteric fractures.It will be administered by anaesthesist.Those assigned to the placebo group will receive an equivalent volume bolus of saline at the time of surgical incision. Peri operatively the transfusion trigger will be hemoglobin concentra
Brief Name:Tranexamic Acid(TXA) usage in hip fracture surgery 1 gram of intravenous Tranexamic acid(TXA) mixed in 100 cc of saline, bolused at the time of surgical incision in operation theatre to patients with dynamic hip screw fixation for intertrochanteric fractures.It will be administered by anaesthesist.Those assigned to the placebo group will receive an equivalent volume bolus of saline at the time of surgical incision. Peri operatively the transfusion trigger will be hemoglobin concentration equal to 9 g dl-1 for all patients.When these triggers are met whole blood will be transfused. Only for patients at risk (acute coronary syndrome, severe left ventricular dysfunction, or chronic respiratory failure), if hypotension could not be corrected despite adequate volume replacement during surgery and in case of syncope, transient ischaemic attack, stroke, acute respiratory failure, or acute coronary syndrome after surgery the transfusion trigger will be hemoglobin concentration of 10 g dl-1.During surgery, blood losses will be replaced with Ringer's lactate in a 3:1 ratio, with 6% hydroxyethyl starch 130/0.4 (Voluven, Fresenius Kabi, Bad Homburg, Germany) in a 1:1 ratio, or both until haemoglobin concentration fell bellow the transfusion trigger point. Thereafter, patients will receive 1 unit of allogeneic packed red cell hourly at a time until haemoglobin concentration raised above the transfusion trigger. Postoperative fluid therapy will be standardized for the first 12 hours. Each patient received 15 ml kg-1 of rehydration fluid (Na 40 mmol l-1, K 20 mmol l-1, glucose 250 mmol l-1).
Sponsors
Dr.Faaiz Ali Shah
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Patients of either gender 18 years and above. 2. Trochanteric fracture types AO 31-A1, A2. 3.Received within one week after sustaining the fracture 4.American Society of Anesthesiologists (ASA) scores of I & II
Exclusion criteria
1.Pre operative hemoglobin <10gm/dl. 2.Allergy to tranexamic acid 3.Severe dysfunction of heart, lung, liver, kidney, or coagulation. 4.Provoked deep venous thrombosis or pulmonary embolism within 30 days or myocardial infarction, cerebrovascular accident, or stent placement within 6 months. 5.Anticoagulant therapy such as antiplatelet drugs or warfarin before surgery. 6. Multiple fractures 7.Pathological fractures 8.Open fractures 9.Periprosthetic fractures 10.Pregnancy
Outcome results
None listed