Vascular Access in Hematological Patients - PICC Versus CVC

Study Overview
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Brief Summary
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The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).

Detailed Description
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The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.

Official Title
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Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Device: Centrally inserted central catheters (CICCs)
* Device: Peripherally inserted central catheters (PICCs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 yrs Newly diagnosed AML Suspected survival > 4 weeks Need of central venous access >4 weeks Exclusion Criteria: Ongoing uncontrolled systemic infection Presence of significant thrombosis/stenosis in arm or central veins Diagnosis of another cancer within 12 months before AML onset any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy Unability to communicate and/or to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripherally inserted central catheters<br>Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs | Device: Peripherally inserted central catheters (PICCs)<br>* Randomization between two well established clinical routine vascular access devices<br>|
| Active Comparator: Centrally inserted central catheter<br>Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs | Device: Centrally inserted central catheters (CICCs)<br>* Randomization between two well established clinical routine vascular access devices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter-related bloodstream infections | 1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications | 2. Occurrence of complications associated with catheter positioning (serious bleeding, arterial puncture and/or pneumothorax), catheter malfunctions (dislocation, occlusion and/or rupture), catheter removals and 30-days overall mortality. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICC, BLOODSTREAM INFECTIONS, VASCULAR ACCESS, DEEP VEIN THROMBOSIS, CICC