Study Stopped
The NHLBI BSMB recommended closure due to poor enrollment.
Dipyridamole/Magnesium To Improve Sickle Cell Hydration
2 other identifiers
interventional
N/A
1 country
3
Brief Summary
The purpose of this study is to determine the benefits as well as side effects of giving drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 11, 2006
CompletedFirst Posted
Study publicly available on registry
January 13, 2006
CompletedAugust 7, 2013
August 1, 2013
January 11, 2006
August 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess effects on red cell hydration.
To assess effects on red cell survival. Measurements will be performed before and after treatment.
Secondary Outcomes (2)
To monitor side effects of each treatment arm.
To evaluate clinical outcomes during each phase of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with homozygous sickle cell (Hb SS) confirmed by hemoglobin electrophoresis or HPLC
- Patients with adequate cardiac, renal, and liver function
- Patients with baseline fetal hemoglobin (Hb F) level of 10% or less
- Patients with at least 6% dense cells or higher at initial screening visit
- Patients with no history of coronary heart disease
- Patients with normal baseline ECG
- Patients with no history of hypotension or hypotensive episodes
You may not qualify if:
- Patients who are pregnant, trying to become pregnant, or breast feeding
- Patients who are on a chronic transfusion program
- Patients who are unable to take oral medications
- Patients who have significant cardiac, renal, or liver dysfunction
- Patients who are on hydroxyurea
- Patients who have a fetal hemoglobin (Hgb F) level of greater than 10%, or have less than 6% dense cell on initial screen
- Patients who are taking a supplement which contains magnesium
- Patients who are taking aspirin, ibuprofen on a daily basis, or anti-coagulant such as Coumadin on a daily basis
- Patients who have a known underlying coagulopathy (acquired or congenital) or have prolonged PT or PTT at the time of initial screen
- Patients who have had a hypersensitivity to either of the study medications
- Patients who are taking any other study medication(s). Patients will not be excluded if they are on penicillin prophylaxis or folic acid, or use ibuprofen intermittently
- Patients taking tetracycline or sodium polystyrene sulfonate
- Patients on concomitant medications and other therapy must have a wash out period prior to study entry and/or study drug dosing
- Patients with abnormal baseline ECG
- Patients with a history of hypotension or hypotensive episodes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Kalinyak, MD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2006
First Posted
January 13, 2006
Study Start
May 1, 2005
Last Updated
August 7, 2013
Record last verified: 2013-08