An observational study in Pediatric Mmune Thrombocytopenic Purpura, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Assiut University · Observational
To Predicting steroid resistance on children newly diagnosed with immune thrombocytopenic purpura
Immune thrombocytopenia (ITP, platelet counts \< 100 × 109/L) is the most common acquired childhood bleeding disorder, clinically characterized by a low platelet count in the absence of other thrombocytopenia causes [1,2].
The estimated incidence of ITP is 100 cases out of a million people per year; about half of these cases occur in previously healthy children, where it represents the most frequent blood disorder [3].
Most children present with a typical history of acute purpura and bruising after a mild viral infection [4]. In severe cases, intracranial hemorrhage (the most 0.5% serious complication, but also the rarest occurring in adults), gastrointestinal hemorrhage in 1.5 % of children, and genitourinary hemorrhage may occur [5].
The International Working Group on ITP defines ITP according to the following clinical phases [6]. These are as follows:
Newly diagnosed ITP is in the first three months post-diagnosis. Persistent ITP is for 3-12 months. Chronic ITP is for > 12 months. Refractory ITP is the failure to restore count of platelet after splenectomy. For children requiring therapy but without life threatening bleeding, corticosteroids are the recommended first line therapy over IVIG or anti-D [2].
Guidelines from the American Society of Hematology recommend a 5-7-day course of prednisone dosed at 2-4 mg/kg/day [2]. Seventy-five percent of children respond to steroids, with platelets recovering to hemostatic range by 2-7 days [7]. If a more rapid rise in platelets is desired, IV methylprednisolone may be used. Studies comparing outcomes between anti-D versus methylprednisolone [8] and comparing methylprednisolone with dexamethasone [9] showed similar response rates with minor side effects in all groups.
A study shows that 98% of patients with corticosteroid exposure experienced one or more side events, and 38% of patients need to stop or reduce corticosteroid therapy [10].
This research aims to develop a new prediction model to evaluate whether newly ITP patients are at high-risk of corticosteroid resistance, and help clinicians to choose better therapy so we divide patients to two groups, steroid response and steroid resistance.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's planned enrollment of 102 is below the median of 150 across 74 observational studies indexed under Purpura.
Browse Purpura studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children diagnosed ITP and take steroid an treatment
Gender: both six
Exclusion Criteria:
predicting steroid resistance on children with acute immune thrombocytopenic purpura in comparison between steroid resistant group and steroid sensitive group Secondary (subsidiary):
predicting steroid resistance on children with acute immune thrombocytopenic purpura in comparison between steroid resistant group and steroid sensitive group to allow early introduction of alternative therapy before bleeding symptoms occurs and to avoid side effects of steroid use.
Time frame: Baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Assiut University