Staging and Prognosis of Deep Venous Thrombosis of Lower Extremities

August 17, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

Staging Diagnosis and Prognosis of Lower Extremity Deep Venous Thrombosis Based on Magnetic Resonance Imaging: a Prospective Study

Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal coagulation of blood in the deep vein, which usually occurs in the lower extremities. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death. Therefore, the accurate diagnosis and curative effect evaluation of DVT are of great significance to the prognosis of patients. At present, the treatment of DVT includes systematic thrombolysis and catheter contact thrombolysis, among which oral drug thrombolysis has certain advantages in clinical application. However, in the process of thrombosis, the composition of thrombus is different in different periods, thus, defining the staging of thrombus plays an important role in the decision-making of drug treatment. In view of the high resolution of magnetic resonance imaging of soft tissue, thrombus can be directly imaged. Therefore, this project will take the staging diagnosis of deep venous thrombosis as the starting point. Through the development of magnetic resonance imaging, this paper tries to solve the problem of evaluating the therapeutic effect of deep venous thrombosis in clinic.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Deep venous thrombosis (DVT) is a venous reflux disorder caused by abnormal blood coagulation in the deep vein, which usually occurs in the lower extremities. DVT is common in patients with limb immobilization (such as after major orthopedic surgery), severe trauma, tumor, coma or long-term bedridden patients. After thrombosis, venous valve function is often destroyed, causing lower limb swelling, ulcers and other congestive diseases, affecting the quality of life of patients; thrombus shedding is also easy to cause pulmonary embolism, serious cases can lead to sudden death.

In the process of thrombosis, the components of thrombus are different in different stages. in the acute stage of thrombosis, the consumption of blood fibroses is less, mainly in the thrombolytic therapy of activating plasminogen; in the subacute and chronic phase of thrombosis, the consumption of fibrinolytic enzyme is more, anticoagulant therapy is needed to prolong the clotting time. Therefore, defining the staging of thrombus is the key to make a reasonable treatment plan and improve the therapeutic effect of DVT. The guidelines recommend that for patients with moderate or high likelihood of DVT, if two consecutive ultrasound examinations are negative, further X-ray venography, CT venography or magnetic resonance venous thrombosis direct imaging are recommended. Among them, magnetic resonance thrombus direct imaging depends on the content of methemoglobin in the body and will not produce radiation to the human body. it can not only accurately judge the thrombus in the pelvic and inferior vena cava, but also show the details of the changes in the vein wall or lumen. Therefore, magnetic resonance thrombus direct imaging has a certain potential in the differential diagnosis of acute, subacute and old thrombus. In this study, we will use magnetic resonance thrombus direct imaging to stage and judge the efficacy of drug treatment, in order to provide help for clinic.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The people included in this study are patients suspected of deep venous thrombosis of lower extremities for the first time and should be older than 18 years old.

Description

Inclusion Criteria:

  • More than 18 years old
  • Suspected deep venous thrombosis of lower extremities
  • No treatment related to deep venous thrombosis of lower extremities

Exclusion Criteria:

  • Contraindication of magnetic resonance imaging
  • Previous history of deep venous thrombosis
  • History of allergy to magnetic resonance contrast agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute thrombus group
Within 14 days after onset
Other: MRI examination
Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.
Subacute thrombus group
During 15-30 days after onset
Other: MRI examination
Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.
Chronic thrombosis group
More than 15-30 days after onset
Other: MRI examination
Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombus-muscle signal-to-noise ratio
Time Frame: The interval between two MRI examinations per patient is 3 months.
Quantitative analysis of thrombus was performed by magnetic resonance thrombography for the first time, and the curative effect was evaluated again 3 months after clinical treatment.
The interval between two MRI examinations per patient is 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2021

Primary Completion (ANTICIPATED)

June 15, 2022

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (ACTUAL)

February 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2020-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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