Status:
UNKNOWN
Clinical Observation of V-P Shunt and Application of "Three-step Disinfection" to Reduce Post-operative Infection Rate
Lead Sponsor:
Baiyun Liu
Conditions:
Hydrocephalus
Ventriculoperitoneal Shunt
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A randomized, single blind, parallel controlled, multicenter clinical study was performed in which patients who had undergone a cerebrospinal fluid to peritoneal shunt that met the criteria were divid...
Detailed Description
Data Collection: Preoperative symptoms and signs, medical records, imaging data, preoperative functional scores (Glasgow score, ADL score, jnphgsr score) were collected. Data Security Monitoring: 1...
Eligibility Criteria
Inclusion
- Age ≥ 18, regardless of gender.
- Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications.
- Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained.
Exclusion
- Patients who had participated in clinical trials of other drugs or medical devices within 6 months.
- Patients with abnormal coagulation mechanisms or who had received treatment with thrombolytic agents, anticoagulants, or inhibitors of platelet coagulation within 2 weeks, and patients with hemophilia.
- Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined.
- Patients with co-existing infectious diseases.
- Pregnant, lactating female patient.
- Physicians judged other situations in which they could not participate in the trial.
- The subjects themselves or their legal surrogates refused to participate in the clinical trial.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04785248
Start Date
June 30 2021
End Date
April 1 2024
Last Update
June 30 2021
Active Locations (1)
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1
Beijing TianTan Hospital affliated to Capital Medical University
Beijing, Beijing Municipality, China