Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04535206
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-23
Brief Title:
The Relationship Between the Lack of AT-Ⅲ PC PS Activity and PICC-related Thrombosis
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
The Relationship Between the Lack of Plasma Antithrombin Ⅲ Protein C Protein S Activity and Peripherally Inserted Central Catheter Related Thrombosis
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 115 149 and 229 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 1600 1745 and 1709 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 320 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
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 320 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None