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Completed

NCT Number: NCT01598688

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

Blood collection immediately after interrupting CSA infusion

Other

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.

For peripheral blood collection, venous access will be established with a small gauge needle.

The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL.

Other names: Immediate collection

Blood collection five minutes after interrupting CSA infusion

Other

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.

For peripheral blood collection, venous access will be established with a small gauge needle.

The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL.

Other names: Five minutes

Primary outcomes

  1. Cyclosporine levels in blood samples

    Time frame: 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 outcomes

  1. Renal function

    Time frame: 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.

  2. Liver function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Monitoring of Cyclosporine Serum Levels in Hematopoietic Stem Cell Transplantation

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 15, 2012
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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