Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis i… (NCT06729021) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis in Cardiothoracic Patients
Iraq112 participantsStarted 2025-01-20
Plain-language summary
The goal of this observational study is to evaluate the predictive efficacy of the Modified Caprini Risk Assessment Score and D-Dimer in identifying and managing lower extremity venous thrombosis (LEVT) among cardiothoracic surgery patients in Baghdad. The main questions it aims to answer are:
Does combining the Modified Caprini Score with D-Dimer improve the accuracy of predicting lower extremity venous thrombosis (LEVT) compared to using each tool independently? Can these tools effectively guide clinical decisions for lower extremity venous thrombosis (LEVT) prevention and management in this patient population?
Participants will:
Undergo risk assessment for lower extremity venous thrombosis (LEVT) using the Modified Caprini Score and have their D-Dimer levels measured during their hospital stay.
Be monitored for clinical outcomes, including confirmed lower extremity venous thrombosis (LEVT) incidence, need for anticoagulation therapy, and complications such as pulmonary embolism or recurrent thrombosis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inpatients with a hospital stay over 3 days
* Written informed consent obtained from patients or their legal guardians.
* Availability for postoperative follow-up to assess outcomes like LEVT development or related complications.
Exclusion Criteria:
* Preexisting LEVT or Pulmonary Embolism: Diagnosed before the index surgery.
* Severe Coagulopathy: Patients with inherited or acquired bleeding disorders (e.g., hemophilia, advanced liver disease).
* receiving any anticoagulation therapy for any reason.
* patients who did not undergo a postoperative D-dimer test.
* Incomplete Data: missing essential clinical or laboratory data for Modified Caprini Score calculation or D-Dimer measurement.
* Pregnancy: pregnant women or those within six weeks postpartum.
* Noncompliance: Patients unwilling or unable to adhere to study follow-up protocols.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
any episode of VTE (Venous Thromboembolism)
Timeframe: In-Hospital Phase (average of 7 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
2
Caprini risk assessment model scores
Timeframe: Day 1 preoperative (one day prior to surgery)
3
Concentration of D-dimer in Blood Samples
Timeframe: Day 1 postoperative (the first day after surgery)