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

NCT07702903 | Active Not Recruiting

• 1 other identifier: HRÜ/25.11.44
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism; Total Hip Arthroplasty (THA); Deep Vein Thrombosis

Keywords

Care Bundle; Nursing Care; Orthopedic Surgery; Patient Comfort; Early Mobilization; Postoperative Care

Outcome Measures

Primary Outcomes (1)

• Incidence of Venous Thromboembolism (VTE)

  The number of patients who develop symptomatic or asymptomatic Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), as confirmed by physician diagnosis and standard diagnostic imaging methods

  Up to 90 days postoperatively

Secondary Outcomes (7)

• Changes in Calf Circumference

  Up to hospital discharge, an average of 3 days

• Incidence of Clinical Signs of DVT

  Up to hospital discharge, an average of 3 days and at 90 days postoperatively

• Incidence of Clinical Signs of Pulmonary Embolism (PE)

  Up to hospital discharge, an average of 3 days at 90 days postoperatively

• Coagulation Profile (INR levels)

  Preoperatively, and postoperatively up to hospital discharge (an average of 3 days)

• Post-Hip Arthroplasty Comfort Scale

  At hospital discharge, an average of 3 days post-surgery

Study Arms (2)

Intervention Group: Care Bundle

EXPERIMENTAL

Patients in this group receive the comprehensive VTE Prevention Care Bundle. This includes structured preoperative education, early mobilization protocols, specific in-bed exercises, guided fluid management, and continuous monitoring of mechanical prophylaxis.

Other: VTE Prevention Care Bundle

Control Group: Standard Care

ACTIVE COMPARATOR

Patients in this group receive standard routine orthopedic nursing care and medical prophylaxis as prescribed by their physicians. No additional study-specific care bundle interventions are applied.

Other: Standard Routine Care

Interventions

VTE Prevention Care Bundle OTHER

The VTE Prevention Care Bundle is a comprehensive, multi-component nursing intervention designed specifically for patients undergoing hip replacement surgery. It consists of five structured components applied systematically: 1) Face-to-face patient education regarding VTE risks and preventive strategies; 2) Specific in-bed ankle-pumping and range-of-motion exercises; 3) An early and progressive mobilization protocol; 4) Guided daily fluid management; and 5) Continuous monitoring and proper application of mechanical prophylaxis (elastic compression stockings). These components are implemented collectively to synergistically reduce the risk of postoperative venous thromboembolism.

Intervention Group: Care Bundle

Standard Routine Care OTHER

Patients receive standard routine orthopedic nursing care provided by the clinic, including standard physician-prescribed medical prophylaxis and routine mobilization practices, without the specific, structured elements of the VTE Prevention Care Bundle.

Control Group: Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and older.
• Scheduled for elective primary total hip replacement surgery.
• Conscious, oriented, and able to communicate effectively to complete questionnaires and understand education.
• Volunteering to participate in the study and able to provide written informed consent.
• Physically capable of participating in early mobilization and bed exercises postoperatively.

You may not qualify if:

• Previous history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE).
• Known bleeding disorders or coagulation abnormalities (e.g., thrombophilia).
• Contraindications to the use of mechanical prophylaxis/compression stockings (e.g., severe peripheral arterial disease, severe skin lesions, or leg ulcers).
• Severe cognitive impairment, dementia, or psychiatric disorders that prevent cooperation with the study protocol and care bundle.
• Bedridden prior to surgery or having severe neurological/musculoskeletal conditions completely preventing mobilization.

Sponsors & Collaborators

• Murat Erten: lead
• The Scientific and Technological Research Council of Türkiye (TUBITAK): collaborator

Study Sites (1)

Mardin Training and Research Hospital, Kızıltepe State Hospital

Mardin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Officials

• Murat Erten, Lecturer

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

• Ayla Yava, Professor

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hasan Kalyoncu University

Model Details: The study utilizes a non-randomized, sequential parallel-group design. To strictly prevent the risk of treatment contamination-where control group patients might observe and request the specialized care bundle interventions (such as specific education, in-bed exercise routines, and structured mobilization protocols) if placed in the same ward simultaneously-a sequential enrollment strategy was employed. First, all participants for the control group were recruited and evaluated while receiving standard routine hospital care. Following the complete enrollment for the control group phase, the intervention phase commenced. Subsequent eligible patients were then enrolled into the intervention group to receive the VTE Prevention Care Bundle. This temporal separation ensures the methodological integrity of the control group's standard care conditions and eliminates the risk of interaction bias between the two groups.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: June 17, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)