Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601543
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-15
Brief Title:
Steroid Resistance in Pediatric Immune Thrombocytopenic Purpura
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Predictors of Steroid Resistance in Pediatric Acute Immune Thrombocytopenic Purpura
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITP
Brief Summary:
To Predicting steroid resistance on children newly diagnosed with immune thrombocytopenic purpura
Detailed Description:
Immune thrombocytopenia ITP platelet counts lt 100 109L is the most common acquired childhood bleeding disorder clinically characterized by a low platelet count in the absence of other thrombocytopenia causes 12
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 05 serious complication but also the rarest occurring in adults gastrointestinal hemorrhage in 15 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 gt 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 mgkgday 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
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 05 serious complication but also the rarest occurring in adults gastrointestinal hemorrhage in 15 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 gt 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 mgkgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None