Phase 2
N=29
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
Sickle Cell Disease · Vaso-occlusive Crisis
Bottom Line
View on ClinicalTrials.gov: NCT01419977 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Change in D-dimer — 478.8; 260.1 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Dalteparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in D-dimer |
478.8; 260.1 | — |
| PRIMARY Change in Clinical Pain Scores |
-0.9; -2.4 | — |
| PRIMARY Change in Thrombin Generation Assay - Endogenous Thrombin Potential |
13.4; -45.98 | — |
| PRIMARY Change in Clinical Pain Scores |
-0.9; -2.4 | — |
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, 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01419977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.