Phlebotomy for Iron Overload
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Phlebotomy for Iron Overload?
Phlebotomy is shown to be effective in reducing iron levels in patients with iron overload conditions like hemochromatosis and sickle cell anemia, as it helps remove excess iron from the body. Studies indicate that it is a standard and safe treatment option, with a significant decrease in iron markers like ferritin in patients undergoing this therapy.12345
Is phlebotomy safe for treating iron overload?
Phlebotomy is generally safe for treating iron overload, with studies showing it is well-tolerated in children with sickle cell anemia and adults with hemochromatosis. Adverse events are rare, and the procedure is considered safe even when hemoglobin levels are slightly below recommended thresholds.13467
How does the treatment phlebotomy differ from other treatments for iron overload?
Phlebotomy is unique because it involves the removal of blood to reduce excess iron in the body, which is different from other treatments like erythrocytapheresis that remove more red blood cells and iron in a shorter time. It is a standard treatment for conditions like hemochromatosis and is effective in preventing complications of iron overload when started early.128910
What is the purpose of this trial?
This study will evaluate the effectiveness of a test called MCV in guiding phlebotomy (blood drawing) therapy in patients with hemochromatosis an inherited disorder that causes too much iron to be absorbed by the intestine. The excess damages body tissues, most severely in the liver, heart, pancreas and joints. Because iron is carried in the hemoglobin of red blood cells, removing blood can effectively lower the body s iron stores.Patients with hemochromatosis undergo weekly phlebotomy treatments (1 pint per session) to deplete iron stores. This usually requires 10 to 50 treatments, after which blood is drawn every 8 to 12 weeks to prevent a re-build up of iron. A test that measures ferritin a protein involved in storing iron is commonly used to guide phlebotomy therapy in hemochromatosis patients. This study will compare the usefulness of the ferritin test with that of MCV, which measures red blood cell size, in guiding phlebotomy therapy. In addition, the study will 1) examine whether keeping iron levels low during maintenance therapy can help heal severe liver disease and improve arthritis in affected patients, and 2) design a system for making blood collected from hemochromatosis donors available for transfusion into other patients.Patients 15 years and older with diagnosed hemochromatosis or very high iron levels suggesting possible hemochromatosis may be eligible for this study. Candidates will have a history, physical evaluation, review of medical records and blood tests, and complete a symptoms questionnaire. Participants will have the following procedures:* Phlebotomy therapy every 1 to 2 weeks, depending on iron levels* Blood sample collection for blood cell counts and iron studies at every phlebotomy session* Blood sample collection (about 2 tablespoons) every 1 to 2 weeks after iron stores have been depleted* Phlebotomy every 8 to 12 weeks after iron stores are used up to prevent re-build up of excess ironWith each blood donation that will be made available for transfusion to other patients, participants will answer the same health history screening questions and undergo the same blood tests given to all regular volunteer blood donors. These include screening for the HIV and hepatitis viruses and for syphilis.Patients who meet height and weight requirements may be asked to consider "double red cell" donations using apheresis. In this procedure, whole blood is collected through a needle placed in an arm vein, similar to routine phlebotomy. The blood then circulates through a machine that separates it into its components. The red cells are removed and the rest of the blood is returned to the body, either through the same needle or through a second needle in the other arm. Patients who have very high iron levels or an enlarged liver will be offered evaluation by the NIH Liver Service. Those judged to be at increased risk for cirrhosis may be advised to undergo a liver biopsy. If cirrhosis is found, the patient will be asked to consider a repeat biopsy after 3 to 5 years of continuous iron depletion to see if scarring has improved. Patients with arthritis will be offered evaluation by the NIH Arthritis Service and, depending on symptoms, may be advised to have X-ray studies or a joint biopsy.
Research Team
Kamille A West-Mitchell, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Eligibility Criteria
This trial is for individuals aged 15 or older with diagnosed hemochromatosis, a condition where too much iron is absorbed by the body. It's also open to those with high iron levels suggesting hemochromatosis, and family members being screened for it. People can't join if they're under 15, need phlebotomy for other conditions like polycythemia vera, have certain illnesses that increase risk, are pregnant, or have iron overload not caused by hemochromatosis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Phlebotomy Treatment
Participants undergo weekly phlebotomy treatments to deplete iron stores, requiring 10 to 50 treatments
Maintenance Phlebotomy
Blood is drawn every 8 to 12 weeks to prevent re-build up of iron
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of liver and arthritis symptoms
Treatment Details
Interventions
- Phlebotomy
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institutes of Health Clinical Center (CC)
Lead Sponsor