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

Overseen by Nirmish 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.

Research Team

Nirmish Shah, MD

Principal Investigator

Duke University

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.

Treatment Details

Interventions

• Dalteparin (Anticoagulant)
• Placebo (Other)

Participant Groups

Group I: Dalteparin Experimental Treatment 1 Intervention

5000 unites subcutaneously, Other Name: Fragmin

Group II: Placebo Placebo Group 1 Intervention

Normal saline solution

Dalteparin is already approved in Canada for the following indications:

Approved in Canada as Fragmin for:

• Prevention of deep vein thrombosis
• Treatment of deep vein thrombosis
• Prevention of pulmonary embolism

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Eisai Limited

Industry Sponsor

Trials

63

Recruited

14,300+

Founded

N/A

Headquarters

N/A

Known For

Neurology & Oncology

Top Products

LEQEMBI, Lenvima, Halaven, Fycompa

Haruo Naito

Eisai Limited

Chief Executive Officer since 1988

Bachelor's degree in Economics from Keio University

Lynn Kramer

Eisai Limited

Chief Medical Officer

MD from Tokyo Medical University