New Candidate Criteria for Diagnosis of Macrophage Activation Syndrome (MAS-D)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01095146|
Recruitment Status : Unknown
Verified March 2010 by Amrita Institute of Medical Sciences & Research Center.
Recruitment status was: Enrolling by invitation
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
Macrophage activation syndrome(MAS) is a complication of bone marrow suppression, coagulopathy and CNS dysfunction which occurs in rheumatic diseases. Normally the (Hemophagocytic Lympho-Histiocytosis) HLH-2004 criteria is used to diagnose patients with MAS. However this criteria is probably not sensitive and would probably be fulfilled quite late into the disease. Thus there would be an unacceptable delay. Ravelli et al came up with a different set of criteria based on data of patients reported in literature.
Systemic onset juvenile idiopathic arthritis (SoJIA) is the most common cause of MAS. MAS in other rheumatic illnesses occurs in the setting on unbridled inflammation. In both SoJIA and uncontrolled rheumatic disease the patient is liable to have high WBC counts and high platelet counts. Bone marrow suppression which is one of the pathognomic features of MAS would be picked up very late if absolute cut off values were utilized. Kelly et al used the same arguments in their review to suggest that in MAS/Reactive hemophagocytic lymphohistiocytosis(ReHLH), the trend of change in laboratory parameters would be more useful than absolute cut offs. Hence the investigators propose new candidate criteria which are based on trends of laboratory parameters and seek to determine their utility in comparison to absolute cut offs of HLH or Ravelli criteria. The investigators also wanted to determine that among the Ravelli criteria and HLH-2004 criteria, which were fulfilled earlier in patients diagnosed as having MAS.
Study hypothesis:-Criteria which measure serial trend of laboratory parameters would be fulfilled earlier than absolute cut offs when diagnosing MAS in patients with rheumatic illness.
|Condition or disease|
|Macrophage Activation Syndrome Lymphohistiocytosis, Hemophagocytic|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Comparison of Predictive Ability of New Candidate Criteria for Diagnosis of Macrophage Activation Syndrome|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095146
|Amrita Institute of Medical Sciences|
|Cochin, Kerala, India, 682041|
|Principal Investigator:||Sharath Kumar, MD||Amrita Institute of Medical Sciences|