Cyclosporine (CSA) Level in Blood Samples Collected From Different Lines

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplantation
• Interventions: Other: Blood collection five minutes after interrupting CSA infusion; Other: Blood collection immediately after interrupting CSA infusion

• Registration Number: NCT01598688
• Lead Sponsor: University of Sao Paulo

Brief Summary

The purpose of this study is to verify whether differences exist in cyclosporine levels between the samples collected through peripheral venous access, the catheter line used to infuse the drug and the line not used for infusion immediately after interrupting the drug infusion or five minutes after the interruption.

Detailed Description

Cyclosporine is an immunosuppressant that prevents graft-versus-host disease, has a narrow therapeutic window, and causes nephrotoxicity. For cyclosporine infusion, a tunneled central venous access device is used; however due to the lipophilic properties of the drug, it can adsorb to the catheter surface and falsely raise cyclosporine concentrations in blood specimens. Some authors recommend sample collection through peripheral access only. Others, however, have shown that these can be collected through the catheter line not used to infuse the drug. Controversies still exist, though, regarding the best timing and blood volume to be discarded to collect the sample.

The hypothesis adopted was that drug adsorption occurs in the line used for infusion. Therefore, there is no statistical or clinical difference between the blood sample collected from the peripheral venous access and from the line not used for cyclosporine infusion. Additionally, this difference becomes smaller when waits five minutes between the interruption of the infusion of the drug and the collection of the blood sample.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-15
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients older than 18 years of age who are receiving an allogeneic hematopoietic stem cell transplantation;
• Have a tunneled central venous access device with at least two lines implanted;
• Received cyclosporine administration through this device.

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Exclusion Criteria

• Patients who received cyclosporine infusion through a catheter line other than the one established for this goal.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood collection five minutes after interrupting the drug	Blood collection five minutes after interrupting CSA infusion	Blood samples were collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion five minutes after interrupting the drug infusion.
Blood collection immediately after interrupting the drug	Blood collection immediately after interrupting CSA infusion	Blood samples were collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion immediately after interrupting the drug infusion.

Primary Outcome Measures

Name	Time	Method
Cyclosporine levels in blood samples	At 1 day after the start of the infusion of the drug, and after every seven days during the period the patient is receiving intravenous infusion, an expected average of 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Liver function	Daily since the start of the infusion of the drug, during the period the patient is receiving intravenous infusion, an expected average of 4 weeks.
Renal function	Daily since the start of the infusion of the drug, during the period the patient is receiving intravenous infusion, an expected average of 4 weeks.

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil