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New Candidate Criteria for Diagnosis of Macrophage Activation Syndrome (MAS-D)

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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
Sponsor:
Information provided by:
Amrita Institute of Medical Sciences & Research Center

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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






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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted in the Pediatrics, Internal Medicine, Rheumatology/Clinical Immunology departments of hospitals
Criteria

Inclusion Criteria:

  • All the patients diagnosed as having Macrophage Activation Syndrome at death or discharge from 1st Jan 2004 to 1st Jan 2012, in all the centers enrolled as collaborators of the study would be included in the study

Exclusion Criteria:

  • Subjects with a final diagnosis of (Infection associated hemophagocytic syndrome) IAHS
  • Subjects with a genetic diagnosis of HLH
  • Subjects with a family history (1st degree relative) of a genetic diagnosis of HLH.

Information from the National Library of Medicine

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


Locations
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India
Amrita Institute of Medical Sciences
Cochin, Kerala, India, 682041
Sponsors and Collaborators
Amrita Institute of Medical Sciences & Research Center
Investigators
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Principal Investigator: Sharath Kumar, MD Amrita Institute of Medical Sciences

Publications:
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Responsible Party: Sharath Kumar, Amrita Institute of Medical Sciences & Research Center
ClinicalTrials.gov Identifier: NCT01095146     History of Changes
Other Study ID Numbers: K-PAE-10-284
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010
Keywords provided by Amrita Institute of Medical Sciences & Research Center:
MAS
Hemophagocytosis
Reactive HLH
Macrophage activation syndrome
Systemic onset juvenile idiopathic arthritis
SoJIA
JIA
Additional relevant MeSH terms:
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Lymphohistiocytosis, Hemophagocytic
Macrophage Activation Syndrome
Syndrome
Disease
Pathologic Processes
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases