Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions

June 14, 2017 updated by: National University Hospital, Singapore
This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PICC occlusion in patients requiring long-term central line access for chemotherapy is a recurrent issue. Occlusion is usually managed by administration of fibrinolytic agents, and subsequent removal and re-insertion if unsuccessful.

Locally, the current clinical practice is to use heparinised saline at a concentration of 10U/ml as a locking agent in between use of the PICC line to prevent occlusion. Citrate 4% has antithrombotic and antibacterial properties, which makes it potentially superior to heparin as a locking agent. Citrate chelates ionised calcium in blood, inhibiting calcium-dependent clotting pathways. Also, as a chelating agent, it results in inhibition of growth of micro-organisms. Citrate-based anticoagulation is often preferred over heparin because of its safety and rapid systemic clearance. Citrate also is safe for heparin induced thrombocytopenia patients.

The effects of each agent have been compared in renal patients with central lines on haemodialysis. These studies have demonstrated that 4% citrate is at least equivalent (MacRae, 2008) or even superior (Grudzinski, 2007) to heparin 5000U/ml in preventing catheter occlusions, and superior in preventing infection (Weijmer, 2002).

This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.

Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends. A standardised data tracking form will be used to assess baseline characteristics as well as number of times urokinase was used. Nursing documentation regarding each PICC flushing (standard documentation as per hospital protocol) will be evaluated for number of discrete attempts made to troubleshoot lines without use of urokinase. Positive blood culture results will be recorded for each patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Nationa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age more than or equal to 21 years.
  • Histologic or cytologic diagnosis of haematological or oncological malignancy
  • Signed informed consent from patient or legal representative
  • Patients on antiplatelet therapy may be recruited to the study

Exclusion Criteria:

  • Pregnancy.
  • Anticoagulation - warfarin or heparin or novel oral anticoagulants
  • Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: heparin 10U/ml
Heparinised saline (10U/ml) lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)
Drug: Heparinised saline (10U/ml)
In patients randomised to the heparinised saline arm, the PICC line will be locked with 10U/ml heparinised saline between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends
Experimental: citrate 4%
4% citrate lock in between each catheter use (with standard twice weekly normal saline flushing if catheter not being used)
Drug: Citrate 4%
In patients randomised to the citrate arm, the PICC line will be locked with a total of 1.6ml of citrate 4% (0.8ml per lumen in a double-lumen PICC), between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of catheter occlusion
Time Frame: From post insertion to 6 months or until the catheter is removed, whichever is earlier.
Compare the rates of catheter occlusion in patients who receive citrate 4% as a locking agent, versus those who receive heparinised saline (10U/ml).
From post insertion to 6 months or until the catheter is removed, whichever is earlier.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Line troubleshooting
Time Frame: From post insertion to 6 months or until the catheter is removed, whichever is earlier.
to compare the time to requiring troubleshooting of the line but not amounting to urokinase use
From post insertion to 6 months or until the catheter is removed, whichever is earlier.
Catheter associated bacteraemia
Time Frame: From post insertion to 6 months or until the catheter is removed, whichever is earlier.
to compare the time to development of catheter associated bacteraemia
From post insertion to 6 months or until the catheter is removed, whichever is earlier.
Bleeding complications
Time Frame: From post insertion to 6 months or until the catheter is removed, whichever is earlier.
to compare the time to development of bleeding complications, either local or systemic.
From post insertion to 6 months or until the catheter is removed, whichever is earlier.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/01420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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