Thromboses, VenousPICININCT03908866
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit
A study testing PICC(Peripherally inserted central catheter) and CVC(Central venous catheter ) in people with Thromboses, Venous and Infection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thromboses, Venous, Infection, Economic Problems
- What is being tested?
- PICC(Peripherally inserted central catheter) and CVC(Central venous catheter )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.
Who cannot join
- Insertion of the central catheter in emergency situations;
- Anatomical abnormalities of upper extremity affecting PICC placement;
- Current or recent (within 1 month) diagnosis of bacteremia
- Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;
- Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Hao Liu, MD, 0086-029-85324005, hao_liu@xjtu.edu.cn
Hao Liu, MD
About this study
Official title: Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety
This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.
- Conditions
- Thromboses, Venous, Infection, Economic Problems
- Being tested
- PICC(Peripherally inserted central catheter), CVC(Central venous catheter )
- Medical subject headings
- Venous Thrombosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICC(Peripherally inserted central catheter)Other
The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.
CVC(Central venous catheter )Other
The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.
| Study group | Role | What they receive |
|---|---|---|
| PICC(Peripherally inserted central catheter) | Experimental | Patients randomly assigned to receive a peripherally inserted central catheter(PICC). Receives: Other: PICC(Peripherally inserted central catheter) |
| CVC(Central venous catheter ) | Active comparator | Patients randomly assigned to receive a centrally inserted central venous catheter(CVC). Receives: Other: CVC(Central venous catheter ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombotic complications
radiographically-confirmed upper-extremity deep vein thrombosis
Measured: up to 30 days or be discharged from hospital
mechanical complications
pneumothorax or hematoma caused by puncture
Measured: up to 30 days or be discharged from hospital
infectious complications
catheter related bloodstream infection
Measured: up to 30 days or be discharged from hospital
Secondary outcomes (2)
catheter replacement
obstruction or accidental removal
Measured: up to 30 days or be discharged from hospital
cost effectiveness
The cost of catheter implantation and replacement, as well as the cost of treatment due to catheter-related complications and the resulting financial loss to the patient.
Measured: up to 30 days or be discharged from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboses, VenousStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Liu, MD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908866
- Sponsor's protocol ID
- XJTU1AF2019LSK-2019-032
- Acronym
- PICINI
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety
- ClinicalTrials.gov ID
- NCT03908866
- Acronym / sponsor ID
- PICINI / XJTU1AF2019LSK-2019-032
- Conditions
- Thromboses, Venous, Infection, Economic Problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 9 Apr 2019 (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.
This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICC(Peripherally inserted central catheter) | Experimental | Other: PICC(Peripherally inserted central catheter)Patients randomly assigned to receive a peripherally inserted central catheter(PICC). |
| CVC(Central venous catheter ) | Active comparator | Other: CVC(Central venous catheter )Patients randomly assigned to receive a centrally inserted central venous catheter(CVC). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.
Key exclusion criteria (5 listed)
- Insertion of the central catheter in emergency situations;
- Anatomical abnormalities of upper extremity affecting PICC placement;
- Current or recent (within 1 month) diagnosis of bacteremia
- Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;
- Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;
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 |
|---|---|---|
| PICC(Peripherally inserted central catheter)The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established. | Other | PICC(Peripherally inserted central catheter) |
| CVC(Central venous catheter )The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established. | Other | CVC(Central venous catheter ) |
Primary outcome
thrombotic complications
Time frame: up to 30 days or be discharged from hospital
radiographically-confirmed upper-extremity deep vein thrombosis
mechanical complications
Time frame: up to 30 days or be discharged from hospital
pneumothorax or hematoma caused by puncture
infectious complications
Time frame: up to 30 days or be discharged from hospital
catheter related bloodstream infection
2 secondary outcomes
catheter replacement
Time frame: up to 30 days or be discharged from hospital
cost effectiveness
Time frame: up to 30 days or be discharged from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
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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.
Hao Liu, MD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICC(Peripherally inserted central catheter) and CVC(Central venous catheter ) in people with Thromboses, Venous and Infection, run by First Affiliated Hospital Xi'an Jiaotong University 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 5 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 23 Apr 2019. 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 Hao Liu, MD (0086-029-85324005, hao_liu@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thrombotic complications (time frame: up to 30 days or be discharged from hospital). The study lists 3 primary outcomes in all. 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 23 Apr 2019.