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

NCT04535206 | Unknown

• 1 other identifier: 2018-005
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Venous Catheter Thrombosis

Outcome Measures

Primary Outcomes (1)

• The incidence of PICC-RVT

  The incidence of PICC-related thrombosis

  8 weeks

Secondary Outcomes (1)

• The incidence of other VTE

  Through study completion, an average of 1 year

Study Arms (2)

With AT-Ⅲ, PC, PS activity decreased

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

Diagnostic Test: Venous blood collecting and test and ultrasound screening

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

Diagnostic Test: Venous blood collecting and test and ultrasound screening

Interventions

Venous blood collecting and test and ultrasound screening 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; With AT-Ⅲ, PC, PS activity decreased

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tumors and have PICC intubation in this tertiary hospital are recruited in order.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Upper Extremity Deep Vein Thrombosis

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jingfen Jin, Master

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Yun Shi, Bachelor

CONTACT

0571-87783887; t574404873@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: September 1, 2020
• Study Start: August 30, 2018
• Primary Completion: August 30, 2021
• Study Completion: October 30, 2021
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

CN (1)