Safety and Efficacy of Iron Reduction by Phlebotomy
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|ClinicalTrials.gov Identifier: NCT00689182|
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : January 31, 2017
Hypothesis: The reduction of total body iron by phlebotomy will be safe and feasible in the post-HSCT setting
Iron overload is common after hematopoietic stem cell transplantation. It is associated with chronic liver disease, with increased rates of infection and decreased survival.
Eligible, consenting patients will have once monthly phlebotomy procedures (500ml) for 12 months.
SAFETY: At each visit, patients will have a comprehensive assessment prior to starting and after completing the phlebotomy. This assessment will include determination of pain at phlebotomy site, local infection and an assessment of symptoms of anemia including presyncope, fatigue and dyspnea. The patient's pulse, blood pressure, respiratory rate and temperature will also be determined before and following the phlebotomy.
EFFICACY: Iron stores will be measured serially in each patient. Measurements will be performed prior to the start of phlebotomy, and at 6 months and 12 months following the start of the series of 12 phlebotomies. These evaluations will be undertaken regardless of the number of phlebotomies which the patient actually undergoes. Iron stores will be estimated by measuring serum ferritin and transferrin saturation levels. Total body iron will be estimated from hepatic and cardiac iron concentration as measured by magnetic resonance imaging (MRI). Gandon et al. (12) described a non-invasive technique using MRI to measure hepatic iron stores. Iron is a paramagnetic substance which causes local magnetic field inhomogeneities leading to dephasing and signal loss in MRI. Gradient echo sequences are most susceptible to their effects because they do not use a 180° refocusing pulse, unlike conventional spin-echo sequences. Gandon et al. used multiple gradient echo sequences, compared the signal in liver to adjacent muscle and used this ratio to correlate with hepatic iron levels measured on tissue biopsy samples using spectrophotometric analysis. Multiple sequences were used because the nomogram comparing the L/M signal ratio is linear over only a small concentration of tissue iron.
|Condition or disease||Intervention/treatment||Phase|
|Iron Overload||Procedure: monthly phlebotomy x 12 months||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of the Safety and Efficacy of Iron Reduction by Phlebotomy in Recipients of Hematopoietic Stem Cell Transplants|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
All patients will receive phlebotomy
Procedure: monthly phlebotomy x 12 months
All patients will receive monthly phlebotomies.
- Iron stores, total body iron [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689182
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3h 2Y9|
|Principal Investigator:||Andrea Kew, MD||Queen Elizabeth II Health Sciences Centre|