The Relationship Between the Lack of AT-Ⅲ, PC, PS Activity and PICC-related Thrombosis

NCT ID: NCT04535206

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

UNKNOWN

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-30

Study Completion Date

2021-10-30

Brief Summary

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

PICC related venous thrombosis (PICC-RVT) is one of the common complications of PICC and the main cause of unplanned extubation. Effectively identifying the risk of PICC-RVT in patients and preventing PICC-RVT are of great clinical significance. There are many studies on the risk factors of VTE at home and abroad, and there are also many studies on the risk assessment of PICC catheter-related thrombosis, mostly focusing on sociodemographic data, comorbidities, and intubation related factors, while the research on laboratory related indicators is limited It involves D-dimer, white blood cell count (WBC), platelet count (PLT), etc., but its specificity or positive predictive value is not high, and there is no reliable biomarker report. Studies have shown that the decrease or lack of AT-Ⅲ, PC, PS activity is one of the mechanisms of hypercoagulable state in patients with cancer, and may be a biomarker of thrombosis. Many retrospective studies have also shown that the activities of AT-Ⅲ, PC, and PS are related to the occurrence and recurrence of VTE and DVT. The pathogenesis is mainly anticoagulant protein defect or decreased expression. However, when PICC is implanted in patients with AT-Ⅲ, PC and PS activity defects, whether PICC indwelling will become a predisposing factor of thrombosis is not yet known. Therefore, the purpose of this study is to understand the rate of anticoagulant protein deficiency in patients with tumor PICC-RVT, and to prospectively explore the correlation between the lack of AT-Ⅲ, PC, and PS activities and PICC-RVT, and to provide targeted preventive interventions for PICC-RVT patients Scientific basis.

Detailed Description

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

A prospective study showed that a mild reduction in AT levels (70%-80%) was associated with the recurrence of no incentive VTE. Subsequent studies defined mild AT deficiency as less than the 5th percentile of the normal range to further verify that mild AT deficiency is a risk factor for VTE recurrence. Many retrospective studies have also shown that the activities of AT-Ⅲ, PC and PS are related to the occurrence and recurrence of VTE and DVT. Taking the lower limit of the normal reference value as the criterion for judging the lack of anticoagulant protein activity, Zhu Tienan et al. found that the lack of activity of AT, PC, and PS in normal people were 1.15%, 1.49%, and 2.29%, respectively. Fang Biqian et al. found 277 cases of VTE. Among the cases found that the lack of activity of AT, PC, and PS were 16.00%, 17.45%, and 17.09%, respectively. That is, the lack of activity of the three anticoagulant proteins in VTE patients was about 10 times higher than that of normal people. Chinese scholars from Taiwan, Hong Kong and Shanghai also found that the total lack of three anticoagulant proteins of AT-Ⅲ, PC and PS exceeds 15% in Western countries, suggesting that the etiological composition of venous thromboembolism in the Chinese population may be similar to that of Western countries. Different, reflecting that anticoagulant protein deficiency plays an important role in the pathogenesis of VTE patients in China. Compared with factor V Leiden mutation and prothrombin 20210A mutation, the most common thrombosis in Asian population is antithrombin Ⅲ (AT-Ⅲ), protein C (protein C, PC) and protein S (protein S, PS), etc. Defects of anticoagulant protein. When the hypercoagulable state caused by anticoagulant protein deficiency is induced by certain risk factors for thrombosis, such as pregnancy, oral contraceptives, fractures, long-term immobilization, etc., it can lead to the occurrence of VTE. When PICC is implanted in patients with AT-Ⅲ, PC and PS activity defects, whether PICC indwelling will become a predisposing factor of thrombosis is not yet known.

It has been reported that the severity of CVC-related thrombosis in patients with AT-Ⅲ deficiency after CVC catheterization is higher than that of the normal group. Nowak-Göttl et al. showed that PC and PS genetic defects are related to catheterization in children Thrombosis plays an important role. In 2016, a systematic review showed that the risk of DVT related to more than one anticoagulant defect increased by 3.20 times. PC defects can increase the incidence of CVC-related DVT in children. Our preliminary study of this subject found that the lack of anticoagulant protein in PICC-RVT patients was higher than that in non-PICC-RVT patients.

Conditions

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

Central Venous Catheter Thrombosis

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With AT-Ⅲ, PC, PS activity decreased

Any decreased in AT-Ⅲ, PC, PS activity before catheter intubation is regarded as the exposure group

Venous blood collecting and test and ultrasound screening

Intervention Type DIAGNOSTIC_TEST

To collect the venous blood samples before the PICC catheterization, and perform ultrasound examination before and after the catheterization at the specified time point in follow-up.

AT-Ⅲ, PC, PS activity are at normal value

The activities of AT-Ⅲ, PC and PS are all at normal values before catheter intubation

Venous blood collecting and test and ultrasound screening

Intervention Type DIAGNOSTIC_TEST

To collect the venous blood samples before the PICC catheterization, and perform ultrasound examination before and after the catheterization at the specified time point in follow-up.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venous blood collecting and test and ultrasound screening

To collect the venous blood samples before the PICC catheterization, and perform ultrasound examination before and after the catheterization at the specified time point in follow-up.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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

Inclusion Criteria

* Age ≥18 years; Patients with solid tumors in line with the indications for catheterization; PICC Intubation and maintenance in this hospital; Expected catheter indwelling time ≥8 weeks; Willing to cooperate with this study and sign an informed consent

Exclusion Criteria

* With Pregnant; with mental diseases who cannot cooperate; Incomplete clinical data; The catheter tip position is not in the best position or the catheter-to-venous ratio ≥45% (vascular diameter≤2.93 mm); Have thrombosis in 3 months before intubation; Be undergoing thrombolysis or anticoagulation therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jingfen Jin, Master

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Medical College of Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yun Shi, Bachelor

Role: CONTACT

0571-87783887

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jingfen Jin, Master

Role: primary

0571-87783887

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.