~2 spots leftby Apr 2026

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

Recruiting in Palo Alto (17 mi)
Overseen byNirmish Shah, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Duke University
Prior Safety Data
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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,
admit diagnosis of vaso-occlusive crisis.
See 1 more

Treatment Details

Interventions

  • Dalteparin (Anticoagulant)
  • Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DalteparinExperimental Treatment1 Intervention
5000 unites subcutaneously, Other Name: Fragmin
Group II: PlaceboPlacebo Group1 Intervention
Normal saline solution

Dalteparin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Fragmin for:
  • Prevention of deep vein thrombosis
  • Treatment of deep vein thrombosis
  • Prevention of pulmonary embolism
  • Treatment of unstable angina and non-Q-wave myocardial infarction
🇺🇸 Approved in United States as Fragmin for:
  • Prevention of deep vein thrombosis
  • Treatment of acute deep vein thrombosis
  • Extended treatment of deep vein thrombosis
  • Prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction
🇨🇦 Approved in Canada as Fragmin for:
  • Prevention of deep vein thrombosis
  • Treatment of deep vein thrombosis
  • Prevention of pulmonary embolism

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Duke UniversityDurham, NC
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Who Is Running the Clinical Trial?

Duke UniversityLead Sponsor
Eisai LimitedIndustry Sponsor

References