Vascular Access in Hematological Patients - PICC Versus CVC

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT02405728

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Device: Centrally inserted central catheters (CICCs) Device: Peripherally inserted central catheters (PICCs)	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peripherally inserted central catheters Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs	Device: Peripherally inserted central catheters (PICCs) Randomization between two well established clinical routine vascular access devices
Active Comparator: Centrally inserted central catheter 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) Randomization between two well established clinical routine vascular access devices

Arm

Intervention/Treatment

Experimental: Peripherally inserted central catheters

Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs

Device: Peripherally inserted central catheters (PICCs)

Randomization between two well established clinical routine vascular access devices

Active Comparator: Centrally inserted central catheter

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)

Randomization between two well established clinical routine vascular access devices

Outcome Measures

Primary Outcome Measures

Catheter-related bloodstream infections [1 year]
1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.

Secondary Outcome Measures

Other complications [1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof Marco Picardi - Hematology - AOU FEDERICO II	Napoli		Italy

Sponsors and Collaborators

Federico II University

Investigators

Principal Investigator: Marco Picardi, Prof, Hematology - AOU Federico II - Napoli - Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marco Picardi, Prof, Federico II University

ClinicalTrials.gov Identifier:

NCT02405728

Other Study ID Numbers:

HEM-FEDII-PICC-001

First Posted:

Apr 1, 2015

Last Update Posted:

Apr 10, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Marco Picardi, Prof, Federico II University

PICC

BLOODSTREAM INFECTIONS

VASCULAR ACCESS

DEEP VEIN THROMBOSIS

CICC

Study Results

No Results Posted as of Apr 10, 2018