Central Venous Catheter ThrombosisNCT04535206
The Relationship Between the Lack of AT-Ⅲ, PC, PS Activity and PICC-related Thrombosis
An observational study of Central Venous Catheter Thrombosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Thrombosis
- What is being tested?
- Venous blood collecting and test and ultrasound screening
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2018to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tumors and have PICC intubation in this tertiary hospital are recruited in order.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jingfen Jin, Master, 0571-87783887, zrjzkhl@zju.edu.cn
About this study
Official title: The Relationship Between the Lack of Plasma Antithrombin Ⅲ, Protein C, Protein S Activity and Peripherally Inserted Central Catheter Related Thrombosis
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.
Read the 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 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
- Central Venous Catheter Thrombosis
- Being tested
- Venous blood collecting and test and ultrasound screening
- Medical subject headings
- Upper Extremity Deep Vein Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood collecting and test and ultrasound screeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| With AT-Ⅲ, PC, PS activity decreased | Any decreased in AT-Ⅲ, PC, PS activity before catheter intubation is regarded as the exposure group Receives: 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 Receives: Diagnostic Test: Venous blood collecting and test and ultrasound screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PICC-RVT
The incidence of PICC-related thrombosis
Measured: 8 weeks
Secondary outcomes (1)
The incidence of other VTE
The incidence of other VTE not related to PICC
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start30 Aug 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Catheter ThrombosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingfen Jin, Master, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535206
- Sponsor's protocol ID
- 2018-005
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Lack of Plasma Antithrombin Ⅲ, Protein C, Protein S Activity and Peripherally Inserted Central Catheter Related Thrombosis
- ClinicalTrials.gov ID
- NCT04535206
- Acronym / sponsor ID
- 2018-005
- Conditions
- Central Venous Catheter Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With AT-Ⅲ, PC, PS activity decreased | – | Diagnostic Test: Venous blood collecting and test and ultrasound screeningAny decreased in AT-Ⅲ, PC, PS activity before catheter intubation is regarded as the exposure group |
| AT-Ⅲ, PC, PS activity are at normal value | – | Diagnostic Test: Venous blood collecting and test and ultrasound screeningThe activities of AT-Ⅲ, PC and PS are all at normal values before catheter intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumors and have PICC intubation in this tertiary hospital are recruited in order.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood collecting and test and ultrasound screeningTo 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. | Diagnostic test | AT-Ⅲ, PC, PS activity are at normal value, With AT-Ⅲ, PC, PS activity decreased |
Primary outcome
The incidence of PICC-RVT
Time frame: 8 weeks
The incidence of PICC-related thrombosis
1 secondary outcome
The incidence of other VTE
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingfen Jin, Master study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Thrombosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Shi, Bachelor (0571-87783887, t574404873@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PICC-RVT (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.