Clinical Predictors for Venous Thromboembolism in Patients With a History of Thrombosis (PREDICTORS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

744 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-19

Study Completion Date

2019-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with a history of blood clots are at risk of developing additional clots in the future. Doctors use a tool called a clinical decision rule to tell them how likely it is that a patient has a blood clot and if they should have further testing to look for the clot. This tool may cause doctors to over-diagnosis a recurrent clot because the symptoms may be left over from the previous clot. Correctly diagnosing a recurrent blood clot is very important since there are risks associated with both over-diagnosis and under-diagnosis. If a recurrent blood clot is missed (under-diagnosis) the patient is at risk of death from a clot in the lungs. If blood thinners are prescribed when they are not needed (over-diagnosis), the patient may have to take blood thinners for their lifetime and risk having serious bleeding.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

NCT00788736

Venous Thromboembolism

COMPLETED

Risk Factors for Venous Thromboembolism

NCT00018772

Deep Venous Thrombosis Pulmonary Embolism

COMPLETED

Understanding Risk Factors Involved in Developing a Second Blood Clot.

NCT00261014

Deep Vein Thrombosis

UNKNOWN

Title: Randomized Trial of an EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients

NCT03243708

Venous Thromboembolism

COMPLETED NA

Cohort for Monitoring Patients With Venous Thromboembolic Disease

NCT07016542

Venous Thromboembolic Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Several tools have been developed to standardize the diagnostic management of a suspected first blood clot. One of these tools is the use of a clinical decision rule. Clinical decision rules have been designed to help clinicians make diagnostic and therapeutic decisions at the bedside. A score is computed on the presence of some criteria from the patient's medical history, clinical signs and symptoms. The score provides the probability of a blood clot. The rules can be used in combinations with a simple blood test - called D-dimer - to identify patients at low risk who don't require diagnostic imaging testing. Benefits include reduced costs, length in hospital and radiation exposure.

Patients with prior blood clots have been shown to be less likely to benefit from the non-invasive testing. Therefore, they often need to undergo imaging tests, which are frequently difficult to interpret in patients with prior blood clots since residual clots are often present and are difficult to distinguish from a recurrent clot.

The objective of this study is to try to prospectively assess the role of existing clinical decision rules in patients with prior blood clots, and to attempt to improve them in order to increase the yield of non-invasive testing and to reduce the risk of over-diagnosis with imaging tests.

With respect to this study, clots within the deep veins of the legs are called deep vein thrombosis (DVT), while clots in the lungs are called pulmonary embolism (PE).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thromboembolic Disease Recurrent Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Recurrent Thromboembolic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Outpatients with clinically suspected acute recurrent DVT or PE regardless of whether the previous event was a DVT or PE
* Age ≥18 years old
* Willing and able to give informed consent

Exclusion Criteria

* Life expectancy less than 3 months
* Suspicion of upper extremity thrombosis or thrombosis at an unusual site (e.g. cerebral or abdominal venous thrombosis)
* Previous VTE was distal DVT or subsegmental PE
* Suspected recurrent VTE is asymptomatic
* Previously enrolled in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No