An observational study in PICC-associated Thrombosis, sponsored by Zhongnan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Zhongnan Hospital · Observational
You will be invited to participate in a clinical study. This informed consent form provides you with some information to help you decide whether to participate in this clinical study. Please read carefully. If you have any questions, please raise them to the researcher in charge of this study. Your participation in this study is voluntary. This research has been reviewed and approved by the Medical Ethics Committee of our hospital. Research objective: peripherally inserted central catheter (PICC) is a commonly used intravenous treatment approach for cancer patients, but catheter-related thrombosis (CRT) is prone to occur after catheterization. Among them, asymptomatic venous thrombosis (referred to as asymptomatic thrombosis) is easily overlooked due to its high concealment and lack of typical clinical manifestations. If not detected and intervened in time, it may lead to serious complications. At present, there is still a lack of effective risk early warning tools specifically for asymptomatic thrombosis related to PICC in tumor patients both at home and abroad. This study aims to collect your clinical data and ultrasound image data to clarify the epidemiological characteristics of the thrombosis, identify its independent risk factors, and construct a high-precision, clinically interpretable joint early warning model, with the goal of providing clinicians with more accurate risk assessment tools and achieving early identification and stratified management of high-risk patients. Ultimately, it reduces the incidence of thrombosis and improves the prognosis of patients. Research Process: If you agree to participate in this study, we will collect your baseline clinical data, past medical history, tumor diagnosis and treatment, PICC catheterization, and complete set of routine test data. We will conduct color Doppler ultrasound examinations of your upper limb blood vessels before the day of catheterization and on the 7th, 14th, 30th, and 60th days after catheterization, record vascular blood flow parameters, and screen for asymptomatic thrombosis. We will number each participant and establish a medical record file. This study plans to recruit 1,655 people. The study period starts from the date you sign the informed consent form and the first PICC catheterization and ends at the completion of the last follow-up 60 days after catheterization. Risks and Discomforts: ① This study only uses conventional clinical ultrasound follow-up, which is radiation-free, non-invasive, will not harm your body, and there is no risk of medical harm. ② The fractional ultrasound examination, combined with data collection, will take up a little of your time and will not bring you additional examination fees. We will strictly protect all your personal information. However, in theory, there is a very small possibility of information leakage. Our hospital will adopt multiple confidentiality measures to minimize this risk to the greatest extent. Benefits: ① Color Doppler ultrasound of the upper limb before catheterization is a mandatory preoperative procedure for PICC catheterization. The cost is already included in your original surgical fee and no additional charges will be applied. At the same time, during the follow-up period after catheterization, you can enjoy four free full-cycle vascular thrombosis ultrasound screenings of the upper limb (on the 7th, 14th, 30th, and 60th days after catheterization). Multiple vascular screenings throughout the process can detect hidden asymptomatic thrombosis as early as possible, allowing for timely intervention and avoiding serious risks such as treatment interruption and pulmonary embolism caused by thrombosis. Your medical record data can assist in the clinical development of simple thrombosis risk assessment tools. In the future, patients with similar tumors undergoing catheterization can quickly predict thrombosis risks, reduce excessive color Doppler ultrasound examinations, and save time and examination costs. Privacy issue: Your relevant medical records will be kept at the hospital. Only researchers, research authorities, and ethics committees are permitted to access your medical records. Any public reports regarding the results of this study will not disclose your personal identity. We will make every effort to protect the privacy of your personal medical information within the scope permitted by law. You may choose not to participate in this study, or notify the researcher at any time to withdraw from the study. Your data will not be included in the study results, and your medical benefits and rights will not be affected as a result. As a research subject, you have the following responsibilities: to provide true information about your medical history and current physical condition; Inform the research doctor of any discomfort you experienced during this study period; Do not take restricted drugs, foods, etc. Inform the research doctor whether you have participated in other studies recent
Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult cancer patients requiring the insertion of PICC
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Age ≥18 years old; Malignant tumors were diagnosed through pathological/cytological examination. For the first time receiving PICC catheterization of the upper limb, the estimated indwelling duration of the catheter> 48 hours; The expected survival time is ≥2 months, and it can cooperate to complete the full vascular ultrasound follow-up and data collection after catheterization.
The test indicators of blood routine, coagulation picture and D-dimer within 7 days before catheterization were normal.
Voluntarily sign the form.
Exclusion Criteria:
- There are absolute for PICC catheterization:① Clearly allergic to PICC catheterization consumables; ② There is a history of infection, injury, radiotherapy or surgical operation at the puncture site; ③ The upper limb vein to be punctured already has thrombosis, complete vein occlusion, severe congenital vascular malformations, and severe vascular stenosis; ④ Severe uncorrected coagulation dysfunction; ⑤ Superior vena cava syndrome; End-stage multiple organ failure In the past 30 days, various anticoagulant drugs such as warfarin, low molecular weight heparin, rivaroxaban, or antiplatelet drugs such as aspirin have been used; Previously received systemic thrombolysis or catheter interventional thrombolysis therapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the maintenance of PICC catheters, color Doppler ultrasound is used to screen for thrombosis in both upper limbs of the patient
The time when the patient developed asymptomatic PICC-related venous thrombosis
Time frame: two months after the PICC catheter was inserted
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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