Study protocol: haemostatic efficacy and safety of preemptive antifibrinolysis with multidose intravenous tranexamic acid in elderly hip fracture patients: design of a prospective randomised controlled trial
Open Access
- 10 December 2021
- Vol. 11 (12), e047382
- https://doi.org/10.1136/bmjopen-2020-047382
Abstract
Introduction Hip fracture surgery is often associated with substantial blood loss and a high allogeneic blood transfusion (ABT) rate. Preoperative hidden blood loss (HBL) has been observed clinically but there is little evidence for the efficacy of tranexamic acid (TXA) in controlling preoperative HBL. We designed a randomised controlled trial to evaluate the efficacy of preemptive antifibrinolysis with multidose intravenous TXA (IV-TXA) in reducing preoperative HBL in elderly patients with hip fractures. Methods and analysis This is a prospective, randomised, placebo-controlled clinical trial. Patients older than 65 years diagnosed with primary unilateral femoral neck fracture or intertrochanteric fracture will be randomly assigned to group A (receiving 100 mL of intravenous normal saline every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days) or group B (receiving 1.5 g of IV-TXA every 12 hours preoperatively and 1.5 g of IV-TXA every 12 hours postoperatively for 3 days). The primary outcomes will be the hidden blood loss, haemoglobin decrease and ABT rate. The secondary outcomes include the levels of inflammatory factors (such as C reactive protein) and coagulation and fibrinolysis parameters (such as D-dimer). Other outcomes such as injury time, length of stay and hospitalisation expenses will also be compared between groups. Ethics and dissemination This study has been approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. The findings of the study will be disseminated through peer-reviewed journals and conference presentations. Trial registration number ChiCTR2100045960.This publication has 30 references indexed in Scilit:
- Epidemiology of hip fracture: Worldwide geographic variationIndian Journal of Orthopaedics, 2011
- Anemia and Patient Blood Management in Hip and Knee SurgeryAnesthesiology, 2010
- Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their preventionBlood, 2009
- Anaemia impedes functional mobility after hip fracture surgeryAge and Ageing, 2008
- Hidden blood loss after surgery for hip fractureThe Journal of Bone and Joint Surgery. British volume, 2006
- Hip FractureThe New England Journal of Medicine, 1996
- Clinical Application of Inhibitors of FibrinolysisDrugs, 1985
- Estimating Allowable Blood LossAnesthesiology, 1983
- Trochanteric Femoral Fractures Treated with McLaughlin OsteosynthesisActa Orthopaedica, 1975
- Antifibrinolytic treatment with tranexamic acid (AMCA) in pediatric urinary tract surgeryJournal of Pediatric Surgery, 1970