Venous ThromboembolismVTE-CARE-THANCT07702903
The Effect of a VTE Prevention Care Bundle in Total Hip Arthroplasty Patients
A study testing VTE Prevention Care Bundle and Standard Routine Care in people with Venous Thromboembolism and Total Hip Arthroplasty (THA), run by Murat Erten at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Total Hip Arthroplasty (THA), Deep Vein Thrombosis
- What is being tested?
- VTE Prevention Care Bundle and Standard Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital, Kızıltepe State Hospital
Mardin
About this study
Official title: Investigation of the Effect of a Venous Thromboembolism Prevention Care Bundle After Hip Arthroplasty: A Non-Randomized Controlled Study
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.
Read more
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.
Read the detailed description
Background and Rationale Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite the routine administration of standard medical prophylaxis, the incidence of VTE can still be significant. This highlights a crucial gap that can be addressed through comprehensive and structured nursing interventions. The implementation of a "care bundle"-a targeted, structured set of evidence-based practices performed collectively and reliably-has been shown to improve patient safety, optimize clinical outcomes, and minimize complications in various high-risk clinical settings.
Study Workflow and Patient Journey This non-randomized controlled clinical trial evaluates the efficacy of a specialized VTE Prevention Care Bundle tailored for patients undergoing total hip arthroplasty. The patient journey begins at the preoperative stage. Candidates are initially screened using the Autar DVT Risk Assessment Scale, which serves strictly as an objective filtering tool to ensure patients meet the precise inclusion criteria regarding their baseline VTE risk.
Eligible participants are then systematically assigned to either the control or intervention phase of the study.
In the control phase, patients receive the standard, routine orthopedic nursing care provided by the hospital ward, alongside the standard pharmacological prophylaxis prescribed by their attending physicians.
In the intervention phase, patients receive the structured VTE Prevention Care Bundle administered by the research team. This bundle is integrated into the daily nursing workflow and focuses on five core pillars: proactive preoperative education (both verbal and written), structured early mobilization, scheduled in-bed ankle-pumping exercises, strict fluid management and hydration tracking, and the continuous monitoring of mechanical prophylaxis (elastic compression stockings).
Data Collection and Longitudinal Follow-Up To accurately capture the impact of the care bundle, the study employs a rigorous 90-day longitudinal follow-up design. Data collection begins with a Descriptive Data Form to capture baseline demographics and clinical characteristics. During the inpatient period, a researcher-developed Clinical Follow-up Chart is utilized to monitor daily physiological parameters, including leg circumference, Homan's sign, localized edema, erythema, vital signs, and International Normalized Ratio (INR) levels for coagulation tracking.
The psychosocial and functional recovery of the patients is also a major focus. Validated tools, including a Postoperative Comfort Scale, a Fear of Falling Scale, and the Newcastle Satisfaction with Nursing Care Scale, are administered to comprehensively assess the patient experience during the mobilization and recovery process.
Following hospital discharge, the monitoring continues seamlessly for 3 months. A specialized Post-Discharge 90-Day Follow-up Chart is used to track the patients in their home environment. This ensures that any hospital admissions or readmissions due to suspected VTE symptoms (such as sudden leg swelling, acute pain, or shortness of breath) are accurately recorded and analyzed.
Funding Status A grant application to support the logistical and material requirements of this clinical research has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under official evaluation.
- Being tested
- VTE Prevention Care Bundle, Standard Routine Care
- Keywords
- Care Bundle, Nursing Care, Orthopedic Surgery, Patient Comfort, Early Mobilization, Postoperative Care
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VTE Prevention Care BundleOther
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.
Standard Routine CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 90 days postoperatively
Secondary outcomes (7)
Changes in Calf Circumference
easurement of calf circumference (in centimeters) using a standard tape measure to monitor for swelling, which is a clinical sign of potential Deep Vein Thrombosis (DVT). Measurements will be taken bilaterally.
Measured: Up to hospital discharge, an average of 3 days
Incidence of Clinical Signs of DVT
The number of patients exhibiting local clinical signs of DVT, including increased localized calf temperature, redness, and tenderness/pain in the lower extremities.
Measured: Up to hospital discharge, an average of 3 days and at 90 days postoperatively
Incidence of Clinical Signs of Pulmonary Embolism (PE)
The number of patients exhibiting clinical signs indicative of PE, such as sudden onset shortness of breath, chest pain, coughing, or tachycardia.
Measured: Up to hospital discharge, an average of 3 days at 90 days postoperatively
Coagulation Profile (INR levels)
International Normalized Ratio (INR) levels will be recorded from patient charts to monitor coagulation status and the effectiveness of medical prophylaxis.
Measured: Preoperatively, and postoperatively up to hospital discharge (an average of 3 days)
Post-Hip Arthroplasty Comfort Scale
Comfort Scale After Hip Prosthesis was used. Total scores range from 26 to 130. Higher scores indicate higher levels of comfort (a better outcome).
Measured: At hospital discharge, an average of 3 days post-surgery
Newcastle Nursing Care Satisfaction Scale
Newcastle Satisfaction with Nursing Care Scale was used. Total scores range from 19 to 95. Higher scores indicate higher levels of patient satisfaction with nursing care (a better outcome).
Measured: At hospital discharge, an average of 3 days post-surgery
Likert-Type Fear of Falling Scale
Likert-Type Fear of Falling Scale was used. Total scores range from 1 to 4. Higher scores indicate higher levels of fear of falling (a worse outcome).
Measured: Preoperatively and at hospital discharge (an average of 3 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start17 Jun 2025
- Primary completion15 Sep 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murat Erten
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Türkiye (TUBITAK)
- Responsible party
- Sponsor-investigator, Murat Erten, Hasan Kalyoncu University
- Investigators
- Murat Erten, Lecturer, Principal investigator, Hasan Kalyoncu UniversityAyla Yava, Professor, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702903
- Sponsor's protocol ID
- HRÜ/25.11.44
- Acronym
- VTE-CARE-THA
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to strictly protect patient privacy and confidentiality. In accordance with the ethical committee approval granted for this study and data protection regulations, the raw data collected from the participants can only be accessed by the primary research team. Only aggregated, fully anonymized, and statistically analyzed data will be disseminated through academic publications, dissertation reports, and scientific presentations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of a Venous Thromboembolism Prevention Care Bundle After Hip Arthroplasty: A Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07702903
- Acronym / sponsor ID
- VTE-CARE-THA / HRÜ/25.11.44
- Keywords
- Care Bundle, Nursing Care, Orthopedic Surgery, Patient Comfort, Early Mobilization, Postoperative Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Murat ErtenUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Türkiye (TUBITAK)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite the routine administration of standard medical prophylaxis, the incidence of VTE can still be significant. This highlights a crucial gap that can be addressed through comprehensive and structured nursing interventions. The implementation of a "care bundle"-a targeted, structured set of evidence-based practices performed collectively and reliably-has been shown to improve patient safety, optimize clinical outcomes, and minimize complications in various high-risk clinical settings.
Study Workflow and Patient Journey This non-randomized controlled clinical trial evaluates the efficacy of a specialized VTE Prevention Care Bundle tailored for patients undergoing total hip arthroplasty. The patient journey begins at the preoperative stage. Candidates are initially screened using the Autar DVT Risk Assessment Scale, which serves strictly as an objective filtering tool to ensure patients meet the precise inclusion criteria regarding their baseline VTE risk.
Eligible participants are then systematically assigned to either the control or intervention phase of the study.
In the control phase, patients receive the standard, routine orthopedic nursing care provided by the hospital ward, alongside the standard pharmacological prophylaxis prescribed by their attending physicians.
In the intervention phase, patients receive the structured VTE Prevention Care Bundle administered by the research team. This bundle is integrated into the daily nursing workflow and focuses on five core pillars: proactive preoperative education (both verbal and written), structured early mobilization, scheduled in-bed ankle-pumping exercises, strict fluid management and hydration tracking, and the continuous monitoring of mechanical prophylaxis (elastic compression stockings).
Data Collection and Longitudinal Follow-Up To accurately capture the impact of the care bundle, the study employs a rigorous 90-day longitudinal follow-up design. Data collection begins with a Descriptive Data Form to capture baseline demographics and clinical characteristics. During the inpatient period, a researcher-developed Clinical Follow-up Chart is utilized to monitor daily physiological parameters, including leg circumference, Homan's sign, localized edema, erythema, vital signs, and International Normalized Ratio (INR) levels for coagulation tracking.
The psychosocial and functional recovery of the patients is also a major focus. Validated tools, including a Postoperative Comfort Scale, a Fear of Falling Scale, and the Newcastle Satisfaction with Nursing Care Scale, are administered to comprehensively assess the patient experience during the mobilization and recovery process.
Following hospital discharge, the monitoring continues seamlessly for 3 months. A specialized Post-Discharge 90-Day Follow-up Chart is used to track the patients in their home environment. This ensures that any hospital admissions or readmissions due to suspected VTE symptoms (such as sudden leg swelling, acute pain, or shortness of breath) are accurately recorded and analyzed.
Funding Status A grant application to support the logistical and material requirements of this clinical research has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under official evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Care Bundle | Experimental | Other: VTE Prevention Care BundlePatients 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. |
| Control Group: Standard Care | Active comparator | Other: Standard Routine CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VTE Prevention Care BundleThe 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. | Other | Intervention Group: Care Bundle |
| Standard Routine CarePatients 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. | Other | Control Group: Standard Care |
Primary outcome
Incidence of Venous Thromboembolism (VTE)
Time frame: Up to 90 days postoperatively
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
7 secondary outcomes
Changes in Calf Circumference
Time frame: Up to hospital discharge, an average of 3 days
Incidence of Clinical Signs of DVT
Time frame: Up to hospital discharge, an average of 3 days and at 90 days postoperatively
Incidence of Clinical Signs of Pulmonary Embolism (PE)
Time frame: Up to hospital discharge, an average of 3 days at 90 days postoperatively
Coagulation Profile (INR levels)
Time frame: Preoperatively, and postoperatively up to hospital discharge (an average of 3 days)
Post-Hip Arthroplasty Comfort Scale
Time frame: At hospital discharge, an average of 3 days post-surgery
Newcastle Nursing Care Satisfaction Scale
Time frame: At hospital discharge, an average of 3 days post-surgery
Likert-Type Fear of Falling Scale
Time frame: Preoperatively and at hospital discharge (an average of 3 days post-surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to strictly protect patient privacy and confidentiality. In accordance with the ethical committee approval granted for this study and data protection regulations, the raw data collected from the participants can only be accessed by the primary research team. Only aggregated, fully anonymized, and statistically analyzed data will be disseminated through academic publications, dissertation reports, and scientific presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Erten, Lecturer principal investigator
Hasan Kalyoncu University
Ayla Yava, Professor study director
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VTE Prevention Care Bundle and Standard Routine Care in people with Venous Thromboembolism and Total Hip Arthroplasty (THA), run by Murat Erten at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Venous Thromboembolism (VTE) (time frame: Up to 90 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.