Perioperative bleeding in femoral shaft fracture patient, operated with plate and screw fixation. tranexamic acid, femoral shaft fracture, femur fracture, ORIF, plate and screw, blood transfusion
Conditions
Interventions
Tranexamic acid injection, 15 mg/kg , intravenous drip in 15-20 minutes, before incision.
,normal saline solution 50 ml , intravenous drip in 15-20 minutes, before incision.
Experimental Drug,Placebo Comparator Drug
tranexamic acid,normal saline solution
Sponsors
Khon Kaen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age > 18 years old 2.Unilateral Femoral shaft fracture (AO classification type A,B) 3.Operated with ORIF with plate and screw
Exclusion criteria
Exclusion criteria: 1.Associated with hemothorax, intra-abdominal bleeding or pelvic fracture 2.Receive more than one operation during admission 3.Contraindicated in tranexamic acid: TXA allergy, acquired defective color vision ,subarachnoid hemorrhage, history of venous or arterial occlusion disease 4.Pregnancy 5.Underlying disease with dependent transfusion 6.Currently using antifibrinolytic or anticoagulant medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| unit of packed red cell transfusion until discharge unit | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin level post op 24 h until discharge g/dL,adverse event of tranexamic acid (Deep vein thrombosis, Pulmonary Embolism, allergy) until discharge event | — |
Countries
Thailand
Contacts
Public ContactRungprae Jiraratmetacon
Khon Kaen Hospital
Outcome results
None listed