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A prospective, multicenter, randomized, parallel-controlled clinical trial comparing the efficacy and safety of drug-coated peripheral central catheters (PICC) inserted with standard peripherally catheters

A prospective, multicenter, randomized, parallel-controlled clinical trial comparing the efficacy and safety of drug-coated peripheral central catheters (PICC) inserted with standard peripherally catheters

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057540
Enrollment
Unknown
Registered
2022-03-14
Start date
2020-01-16
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood tumors requiring long-term chemotherapy

Interventions

experimental group:The drug-containing coating was inserted and a central venous catheter was inserted
control group:Put in a peripheral central venous catheter

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. The patient aged >=18 years and needed PICC insertion, regardless of gender; 2. Physical condition score ECOG=3 months; 4. No malignant tumors of other organ entities were present in diagnosis; 5. Patients with first catheterization or target vein more than 1 year since the last PICC extraction, and no other vascular access devices were indwelled; 6. Patients are willing and able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient had thrombosis in the superior vena cava or vena cava; 2. The patient had allergic history of chlorhexidine; 3. Patients with peripheral or central vein stenosis (catheter area/target vein area >45%); 4. Superior vena cava syndrome was diagnosed; 5. Vascular occlusion or severe lesions at the puncture catheterization site of the patient; 6. Pregnant or lactating patients; 7. Patients are not willing to use contraception as required during clinical trials; 8. Coagulopathy (INR > 2 or aPTT> 66, bleeding and bleeding tendency); 9. Alcoholics or drug addicts, drug abusers; 10. Skin conditions such as inflammation, rash, scabs, drainage, hematoma, phlebitis, or extravasation or exudation of intravenous fluids within 15cm or less from the proposed catheter insertion site; 11. The patient is mentally incapable or unable to understand the requirements of participating in the study; 12. The patient's co-existing diseases limited her participation in the study, and she could not comply with the follow-up or affected the scientific and integrity of the study; 13. Circumstances that are not suitable for participation in this experiment.

Design outcomes

Primary

MeasureTime frame
Rate of first attempt insertion success;The Incidence of catheter-related bloodstream infection ;

Secondary

MeasureTime frame
Incidence of complete loss of catheter function;Incidence of catheter-associated external wall thrombosis;Device performance evaluation;Evaluation of other safety parameters;

Countries

China

Contacts

Public ContactXu Jia

Teleflex Medical Trading Shanghai Company Limited

Jovan.xu@teleflex.com+86 13501133710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026