Clinical Trial: Dexamethasone Efficacy in HELLP I Syndrome
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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.
Detailed Summary: 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.
Sponsor: Universidad del Valle, Colombia
Current Primary Outcome: Duration of hospitalization [ Time Frame: Average: 15 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Recovery time of platelets to more than 100000/mm3 [ Time Frame: Average:7 days ]
- Recovery of AST, ALT and LDH [ Time Frame: Average: 10 days ]
- Transfusion of blood products [ Time Frame: Average: 7 days ]
Original Secondary Outcome: Same as current
Information By: Universidad del Valle, Colombia
Dates:
Date Received: May 10, 2010
Date Started: October 2009
Date Completion: December 2012
Last Updated: June 4, 2010
Last Verified: June 2010
