Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 27 for:    Liver | "hemochromatosis"

Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202436
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 20, 2009
Sponsor:
Collaborators:
Maastricht University Medical Center
Atrium Medical Center
Radboud University
Information provided by:
Sanquin Research & Blood Bank Divisions

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date October 20, 2009
Study Start Date  ICMJE October 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Treatment duration and number of treatments [ Time Frame: Ferritine value 50 microgr/l ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00202436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2009)
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs [ Time Frame: Ferritine value 50microgr/l ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
Official Title  ICMJE Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
Brief Summary In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
Detailed Description In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemochromatosis
Intervention  ICMJE
  • Procedure: Phlebotomy
    Removal of 500 ml whole blood
    Other Name: Bloodletting
  • Procedure: Erythrocytapheresis
    machinal removal of erythrocytes
    Other Name: Therapeutic erythrocytapheresis
Study Arms
  • Active Comparator: 1
    Phlebotomy
    Interventions:
    • Procedure: Phlebotomy
    • Procedure: Erythrocytapheresis
  • Active Comparator: 2
    Erythrocytapheresis
    Interventions:
    • Procedure: Phlebotomy
    • Procedure: Erythrocytapheresis
Publications * Rombout-Sestrienkova E, Nieman FH, Essers BA, van Noord PA, Janssen MC, van Deursen CT, Bos LP, Rombout F, van den Braak R, de Leeuw PW, Koek GH. Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. Transfusion. 2012 Mar;52(3):470-7. doi: 10.1111/j.1537-2995.2011.03292.x. Epub 2011 Aug 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date September 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hereditary haemochromatosis patients

Exclusion Criteria:

  • Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00202436
Other Study ID Numbers  ICMJE PPO-C- 03-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr.Wim de Kort PhD, Sanquin Blood Bank South-east
Study Sponsor  ICMJE Sanquin Research & Blood Bank Divisions
Collaborators  ICMJE
  • Maastricht University Medical Center
  • Atrium Medical Center
  • Radboud University
Investigators  ICMJE
Principal Investigator: Eva Rombout, MD Sanquin Research and Blood Bank Divisions
PRS Account Sanquin Research & Blood Bank Divisions
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP