Vascular Access in Hematological Patients - PICC Versus CVC

Vascular Access Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405728
• Other study ID #: HEM-FEDII-PICC-001
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: April 9, 2018
• Start date: February 2015
• Est. completion date: October 2017

Study information

• Verified date: April 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Device:
• Centrally inserted central catheters (CICCs)
Randomization between two well established clinical routine vascular access devices
• Peripherally inserted central catheters (PICCs)
Randomization between two well established clinical routine vascular access devices

Locations

Country	Name	City	State
Italy	Prof Marco Picardi - Hematology - AOU FEDERICO II	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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