Staging and Prognosis of Deep Venous Thrombosis of Lower Extremities

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04732299
Collaborator
(none)
60
26

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MRI examination

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Staging Diagnosis and Prognosis of Lower Extremity Deep Venous Thrombosis Based on Magnetic Resonance Imaging: a Prospective Study
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Thrombus-muscle signal-to-noise ratio [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04732299
Other Study ID Numbers:
  • XJTU1AF-CRF-2020-014
First Posted:
Feb 1, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021