Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease, Vaso-occlusive Crisis

In brief

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, with hydroxyurea being the only medication approved to reduce the frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no specific therapy is currently available to otherwise affect the course of the VOC. However, there has been increasing interest in the role of coagulation in the pathogenesis of SCD. The investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive process and thereby hasten the resolution of pain.

Key facts

Study ID

NCT01419977

Run by

Duke University

People needed

34

Starts

2011-05-01

Expected to finish

2014-07-01

Last updated by the study team

2015-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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