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NCT01419977 · ClinicalTrials.gov registry record · Phase 2
Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
A Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01419977: Completed Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Duke University.
NCT01419977 is a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis that has completed, run by Duke University. The registered enrollment target is 34 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01419977, a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Patients will have D-dimer,for samples drawn on Day 1 and Day 3
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dalteparin
Study Locations (1)
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01419977 record still lists
NCT01419977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01419977 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01419977 about?
NCT01419977 is a clinical study titled "Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo". 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 (...
What is the current status of trial NCT01419977?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-05. Estimated completion is 2014-07.
What conditions does trial NCT01419977 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis.
What interventions are being tested in trial NCT01419977?
The interventions under investigation include: Placebo (DRUG), Dalteparin (DRUG).
Who is sponsoring clinical trial NCT01419977?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419977 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01419977's enrollment target sits among peer trials
34 135th of 213 higher than 78 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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