CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01419977
NCT01419977Phase 2Completed

Randomized Double Blind Placebo Controlled Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose LMWH Versus Placebo

Duke University·interventional·Posted Aug 19, 2011·Updated Feb 16, 2015

In Brief

A Phase 2 clinical trial evaluating Placebo and Dalteparin for Sickle Cell Disease and Vaso-occlusive Crisis. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEisai Limited

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2011
Enrollment StartMay 1, 2011
Primary CompletionJul 1, 2013
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.9 years ago

Interventions

Placebodrug

Normal saline solution, administered by nursing staff once daily

Dalteparindrug

Low molecular weight heparin (LMWH), 5000 unites subcutaneously, administered by nursing staff once daily, Other Name: Fragmin