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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Monitoring of Cyclosporine Serum Levels in Hematopoietic Stem Cell Transplantation

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Other: Blood collection immediately after interrupting CSA infusion
* Other: Blood collection five minutes after interrupting CSA infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blood collection immediately after interrupting the drug<br>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. | Other: Blood collection immediately after interrupting CSA infusion<br>* 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.<br>* Other names: Immediate collection;|
| Experimental: Blood collection five minutes after interrupting the drug<br>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. | Other: Blood collection five minutes after interrupting CSA infusion<br>* 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.<br>* Other names: Five minutes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow transplantation, Hematopoietic stem cell transplantation, Medication management, Nursing care