Clinical Trial: Sickle Cell Disease: A Retrospective Chart Review

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review

Brief Summary: This study is a retrospective chart review of sickle cell patients and will include patients whom have received blood transfusions and those whom have not. Of the transfused patients, it will also include those whom have received chelation therapy and those whom have not.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Sickle cell complications [ Time Frame: average of 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Utilization of health care delivery to treat sickle cell complications [ Time Frame: average of 5 years ]
  • Overall survival [ Time Frame: average of 5 years ]
  • Utilization of blood transfusions (patients with frequent transfusions only) [ Time Frame: average of 5 years ]
  • Burden of iron overload (patients with frequent transfusions only) [ Time Frame: average of 5 years ]
  • Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only) [ Time Frame: average of 5 years ]


Original Secondary Outcome:

  • Utilization of health care delivery to treat sickle cell complications [ Time Frame: average of 5 years ]
  • Overall survival [ Time Frame: average of 5 years ]
  • Utilization of blood transfusions (patients with frequent transfusions only) [ Time Frame: average of 5 years ]
  • Burden of iron overload (patients with frequent transfusions only) [ Time Frame: average of 5 years ]
  • Utilization of ICTs (patients receiving deferoxamine or deferasirox [Exjade®] only) [ Time Frame: average of 5 years ]


Information By: Novartis

Dates:
Date Received: September 7, 2011
Date Started: July 2011
Date Completion:
Last Updated: October 17, 2012
Last Verified: October 2012