Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509652
Status:
UNKNOWN
Last Update Posted:
2007-07-31
First Post:
2007-07-27
Brief Title:
Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis
Sponsor:
University of Bergen
Organization:
University of Bergen
Study Overview
Official Title:
Therapeutic Effect of Erythrocyte Apheresis as Compared to Full Blood Phlebotomy in Patients With Hereditary Hemochromatosis
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary hemochromatosis is the most frequent hereditary condition in Scandinavia The condition may result in serious organ damage which can be prevented by therapy but only few patients develop such organ damage The optimal treatment therefore is still a matter of discussion Prevention of organ damage has traditionally been accomplished by drawing of full blood phlebotomy which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective removal of red blood cells red cell apheresis Possible drawbacks of this technique may be higher costs prolonged time for each therapeutic procedure and certain requirements to the patients The possible advantages are the reduced number of therapeutic procedures and less strain for the patient No larger randomized study has been published in order to determine which method should be preferred
This study is a controlled trial in which participating patients are asked to be randomized to red cell apheresis or traditional phlebotomy Each group will be followed by means of well-defined assessments in order to explore possible advantages and disadvantages of each method in order to establish what type of treatment should be recommended
This study is a controlled trial in which participating patients are asked to be randomized to red cell apheresis or traditional phlebotomy Each group will be followed by means of well-defined assessments in order to explore possible advantages and disadvantages of each method in order to establish what type of treatment should be recommended
Detailed Description:
Introduction Primary hemochromatosis is the most frequent hereditary condition in Scandinavia The condition may result in serious organ damage which can be prevented by therapy but only few patients develop such organ damage Provided the lack of more exact knowledge of which patients should be treated we have based our inclusion criteria on the guidelines published by the Norwegian Society of Hematology However the criteria for ferritin levels have been set at 300 microgramsL for patients who are homozygous for the C282Y mutation and also heterozygous individuals will be included if ferritin is higher than 500 microgramsL
Furthermore the optimal treatment method is still a matter of discussion Prevention of organ damage has traditionally been accomplished by whole blood phlebotomy which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective withdrawal of red blood cells erythrocyte apheresis Possible drawbacks of this technique may be higher costs prolonged time for each therapeutic procedure and certain requirements to the patients The possible advantages are the reduced number of therapeutic procedures and less strain for the patient No larger randomized study has been published in order to determine which method should be preferred
Hypothesis A more rapid decline of primary endpoints see below can be achieved by erythrocyte apheresis as compared to traditional phlebotomy without significant disadvantages
Design The trial is prospective randomized and open Eligible patients are randomized to erythrocyte apheresis and phlebotomy
Endpoints Primary endpoints Decline of ferritin levels and transferrin saturation
Secondary endpoints and other variables to be studied Decline in hemoglobin levels Discomfort during the therapeutic procedure Any changes in EVF blood cell counts or albumin and CRP levels Certain well-defined financial costs consumed material technician working time
Inclusion criteria
1 Diagnosis
1 Individuals who art homozygous for C282Y or H63D or compound heterozygous for these tow variants and have ferritin levels higher than 300 microgramsL or transferrin saturation higher than 50
2 Individuals heterozygous for C282Y or H63D if ferritin levels higher than 500 microgramsL or transferrin saturation higher than 50
2 Requirements to the patient Body weight higher than 65 kg and initial hemoglobin level higher than 12 gdL
Treatment schedule Following randomization to either apheresis or phlebotomy patients are treated until ferritin levels have declined to below 50 microgramsL and they are then followed for one year Patients randomized to apheresis are treated every second week whereas patients in the phlebotomy group are treated weekly Prolongation of the interval is permitted in both groups in case of well-defined clinical indications Any prolongation is to be recorded along with the clinical indication
Follow-up Clinical symptoms body weight laboratory findings Hemoglobin levels blood cell counts levels of iron transferrin ferritin albumin and IgG serologic assessments for hepatitis viruses CMV and HIV discomfort during the therapeutic procedure duration of each procedure costs for consumed material working time of the technician for each procedure
Furthermore the optimal treatment method is still a matter of discussion Prevention of organ damage has traditionally been accomplished by whole blood phlebotomy which has to be frequently repeated during the initial phase and then continued indefinitely as a maintenance treatment The removed amount of iron may be increased two- or threefold for each procedure by using modern equipment for selective withdrawal of red blood cells erythrocyte apheresis Possible drawbacks of this technique may be higher costs prolonged time for each therapeutic procedure and certain requirements to the patients The possible advantages are the reduced number of therapeutic procedures and less strain for the patient No larger randomized study has been published in order to determine which method should be preferred
Hypothesis A more rapid decline of primary endpoints see below can be achieved by erythrocyte apheresis as compared to traditional phlebotomy without significant disadvantages
Design The trial is prospective randomized and open Eligible patients are randomized to erythrocyte apheresis and phlebotomy
Endpoints Primary endpoints Decline of ferritin levels and transferrin saturation
Secondary endpoints and other variables to be studied Decline in hemoglobin levels Discomfort during the therapeutic procedure Any changes in EVF blood cell counts or albumin and CRP levels Certain well-defined financial costs consumed material technician working time
Inclusion criteria
1 Diagnosis
1 Individuals who art homozygous for C282Y or H63D or compound heterozygous for these tow variants and have ferritin levels higher than 300 microgramsL or transferrin saturation higher than 50
2 Individuals heterozygous for C282Y or H63D if ferritin levels higher than 500 microgramsL or transferrin saturation higher than 50
2 Requirements to the patient Body weight higher than 65 kg and initial hemoglobin level higher than 12 gdL
Treatment schedule Following randomization to either apheresis or phlebotomy patients are treated until ferritin levels have declined to below 50 microgramsL and they are then followed for one year Patients randomized to apheresis are treated every second week whereas patients in the phlebotomy group are treated weekly Prolongation of the interval is permitted in both groups in case of well-defined clinical indications Any prolongation is to be recorded along with the clinical indication
Follow-up Clinical symptoms body weight laboratory findings Hemoglobin levels blood cell counts levels of iron transferrin ferritin albumin and IgG serologic assessments for hepatitis viruses CMV and HIV discomfort during the therapeutic procedure duration of each procedure costs for consumed material working time of the technician for each procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None