Status:
COMPLETED
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eisai Limited
Conditions:
Sickle Cell Disease
Vaso-occlusive Crisis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits highest frequency in people of African descent. Patients with SCD currently have few treatment options, wi...
Detailed Description
This is a double blind prospective randomized placebo controlled study with an enrollment target of 100 patients. All subjects with SCD that meet inclusion criteria while inpatient, will be eligible f...
Eligibility Criteria
Inclusion
- Documented HgbSS or HgbS-beta0 thalassemia by previous hemoglobin electrophoresis,
- age greater than 18 years old, and
- admit diagnosis of vaso-occlusive crisis.
- Labs must be drawn within 36 hours of admission and randomization to treatment arm must occur during this time.
Exclusion
- End stage renal disease (creatinine \>3.0 mg/dL),
- use of antiplatelet or anticoagulation medication for an alternative indication,
- use of steroids or immunosuppressive medications,
- platelet count less than 100 X 109/L,
- history or development of heparin induced thrombocytopenia, packed red blood cell transfusion in the past one month, or
- recent hospitalization with discharge within the past 1 week.
- Patients with re-admissions will not be enrolled again and will have no further samples drawn.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01419977
Start Date
May 1 2011
End Date
July 1 2014
Last Update
February 16 2015
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710