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Anticoagulant

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

Phase 2
Waitlist Available
Led By Nirmish Shah, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 3
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Sickle Cell Crisis
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Clinical Pain Scores
Change in D-dimer
Change in Thrombin Generation Assay - Endogenous Thrombin Potential

Side effects data

From 2014 Phase 4 trial • 87 Patients • NCT00966277
59%
Nausea
47%
Constipation
44%
Vomiting
35%
Abdominal pain
24%
Bruising/minor bleeding
18%
Dyspnea
18%
Myalgia
12%
Anxiety
9%
Bone pain
6%
Dermatology/Skin (Other)
6%
Ocular/Visual (Other)
3%
Depression
3%
Insomnia
3%
Allergic rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Dalteparin
Group 2: Control

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalteparin
FDA approved

Find a Location

Who is running the clinical trial?

Eisai LimitedIndustry Sponsor
62 Previous Clinical Trials
14,234 Total Patients Enrolled
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,513 Total Patients Enrolled
Nirmish Shah, MDPrincipal InvestigatorDuke University
5 Previous Clinical Trials
119 Total Patients Enrolled
~2 spots leftby Dec 2025