Femoral Neck Fracture
Conditions
Keywords
tranexamic acid, femoral neck fracture, bipolar hemiarthroplasty, topical, blood transfusion
Brief summary
The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are: * The efficacy in reducing blood transfusion for topical tranexamic acid administration * The safety of tranexemic acid, topically used As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration. Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.
Detailed description
Perioperative blood loss and transfusion are common in elderly patients undergoing bipolar hemiarthroplasty for femoral neck fractures, and are associated with anemia-related morbidity and transfusion-related risk. Although tranexamic acid (TXA) reduces blood loss and transfusion in elective arthroplasty, topical administration has been proposed to preserve local hemostatic efficacy while limiting systemic exposure in this comorbid population, but the optimal topical route in hip fracture surgery remains uncertain. This study compared the efficacy and safety of topical soaking (TS) and intra-articular (IA) TXA with placebo in patients undergoing bipolar hemiarthroplasty.
Interventions
DRUGRetrograde Intraarticular Injection via Drain Tube
Tranexamic acid will be injected via drain tube after wound closure
DRUGTopical Soaking of Tranexamic Acid
Tranexamic acid will be topically administered by soaking method
DRUGPlacebo Comparator: Standard procedure (placebo)
Standard wound management
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elderly patients (age \> 60 years) * Femoral neck fractures from low energy mechanism * Household ambulator * Undergoing cementless bipolar hemiarthroplasty at KCMH * Informed consent
Exclusion criteria
* Allergy to TXA * History of VTE * History of hip surgery, pathological fracture, hip infection * Congenital or acquired coagulopathy * Hb \< 10 g/dL or Platelet \< 140,000
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood transfusion | 2 years, or until complete enrollment | Proportion of patients received blood transfusion divided by total number of patient in a group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of blood transfusion | 2 years, or until complete enrollment | total volume of blood transfusion per each patient |
| Calculated blood loss | 2 years, or until complete enrollment | Calculating using Nadler and Goss formula |
| Any adverse events | 2 years, or until complete enrollment | Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication |
| In-hospital mortality | During admission period | In-hospital mortality |
Countries
Thailand
Contacts
CONTACTRiewruja, Medical degree
CONTACTTantavisut, MD., PhD.
PRINCIPAL_INVESTIGATORKanyakorn Riewruja, Medical degree
Chulalongkorn University
Outcome results
None listed