Dexamethasone Efficacy in HELLP I Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Universidad del Valle, Colombia.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Universidad del Valle, Colombia
Information provided by:
Universidad del Valle, Colombia
ClinicalTrials.gov Identifier:
NCT01138839
First received: May 10, 2010
Last updated: June 4, 2010
Last verified: June 2010
| Tracking Information | |||||
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| First Received Date ICMJE | May 10, 2010 | ||||
| Last Updated Date | June 4, 2010 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Duration of hospitalization [ Time Frame: Average: 15 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01138839 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dexamethasone Efficacy in HELLP I Syndrome | ||||
| Official Title ICMJE | Dexamethasone Efficacy in HELLP I Syndrome, a Multicentric, Double-blind, Placebo-controlled, Randomized Clinical Trial | ||||
| Brief Summary | The purpose of this study is to determine the efficacy of dexamethasone for treatment of HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome. |
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| Detailed Description | Treatment of HELLP syndrome usually is restricted to measures of support and treatment of complications. In 2005, in a subgroup analysis we showed that, among patients with HELLP 1, there were a shorter average time to platelet recovery and less duration of hospitalization in women who received dexamethasone therapy, however the importance of this finding is diminished because this was an unplanned analysis and the severity of the disease was not taken into account at randomization. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | HELLP Syndrome | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 10 Years to 48 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Colombia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01138839 | ||||
| Other Study ID Numbers ICMJE | 1625, COLCIENCIAS RC No. 334-2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Javier Fonseca, Universidad del Valle | ||||
| Study Sponsor ICMJE | Universidad del Valle, Colombia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universidad del Valle, Colombia | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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