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

NCT01598688 | Completed DMC

• 1 other identifier: CSADOC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Bone marrow transplantation; Hematopoietic stem cell transplantation; Medication management; Nursing care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Blood collection immediately after interrupting the drug

ACTIVE COMPARATOR

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

Blood collection five minutes after interrupting the drug

EXPERIMENTAL

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

Interventions

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.

Also known as: Immediate collection

Blood collection immediately after interrupting the drug

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.

Also known as: Five minutes

Blood collection five minutes after interrupting the drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Study Officials

• Livia M Garbin, RN

  University of Sao Paulo at Ribeirão Preto College of Nursing

  PRINCIPAL INVESTIGATOR

• Emilia C Carvalho, RN, PhD

  University of Sao Paulo at Ribeirão Preto College of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 15, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

BR (1)