Clinical Trial

The Effect of a VTE Prevention Care Bundle in Total Hip Arthroplasty Patients

Study acronym: VTE-CARE-THA
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite standard prophylactic measures, the incidence of VTE can be significant, highlighting the need for comprehensive and structured nursing interventions. A "care bundle" approach-a targeted set of evidence-based practices performed collectively and reliably-has been shown to improve patient outcomes and minimize complications in various clinical settings. This non-randomized controlled clinical trial aims to investigate the effect of a specifically designed VTE Prevention Care Bundle on clinical outcomes in patients recovering from total hip arthroplasty. The central hypothesis is that the systematic implementation of this care bundle will result in optimized clinical parameters, enhanced recovery experiences, and minimized VTE risks compared to standard routine care. Study Design and Population: The study utilizes a quasi-experimental, non-randomized controlled design. Participants are adult patients who have undergone total hip arthroplasty. The Autar DVT Risk Assessment Scale is utilized strictly as an objective filtering tool during the patient selection process (inclusion criteria). Participants are systematically assigned to either a control group or an intervention group based on the study protocol phases. Interventions: Control Group: Patients receive the standard, routine orthopedic nursing care provided by the hospital, alongside the standard medical prophylaxis prescribed by their attending physicians. Intervention Group: Patients receive the specialized VTE Prevention Care Bundle. This comprehensive bundle consists of five core components: Education: Providing verbal and written information to the patient during the preoperative period. Early Mobilization: Ensuring controlled ambulation and mobilization in the early postoperative period. Exercise: Instructing and monitoring in-bed ankle-pumping exercises. Fluid Management: Encouraging adequate hydration and closely monitoring fluid intake. Mechanical Prophylaxis: Ensuring the correct application and continuous monitoring of elastic compression stockings. Data Collection and Follow-up Tools: Data is collected systematically during the inpatient stay and throughout a 90-day post-discharge period using the following tools: Descriptive Data Form: Records demographic and clinical characteristics (age, BMI, surgical history). Clinical Follow-up Chart: A researcher-developed form tracking leg circumference, Homan's sign, edema, erythema, vital signs, and International Normalized Ratio (INR) levels. Comfort Scale After Hip Prosthesis: A 26-item scale used to evaluate the patient's postoperative comfort. Newcastle Satisfaction with Nursing Care Scale: A 19-item scale evaluating patient satisfaction with the nursing care received. Likert-Type Fear of Falling Scale: Assesses patients' fear levels during mobilization. Post-Discharge 90-Day Follow-up Chart: A researcher-developed form utilized to monitor any hospital admissions or readmissions due to suspected VTE symptoms (leg swelling, pain, shortness of breath) during the 3-month follow-up period. Funding Status: A grant application for this research project has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under evaluation.
Trial Details
NCT Number NCT07702903
Lead Sponsor Murat Erten
Collaborators: The Scientific and Technological Research Council of Türkiye (TUBITAK)
Conditions Venous Thromboembolism, Total Hip Arthroplasty (THA), Deep Vein Thrombosis
Enrollment 110 participants
Start Date 2025-06-17
Primary Completion 2026-09-15 (estimated)
Study Completion 2026-10-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-14