Viewing Study NCT05406934


Ignite Creation Date: 2025-12-25 @ 2:21 AM
Ignite Modification Date: 2025-12-31 @ 10:50 PM
Study NCT ID: NCT05406934
Status: UNKNOWN
Last Update Posted: 2022-06-07
First Post: 2022-01-17
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Evaluation of Blood Platelet Indices,Platelet Aggregation in the Activity of IBD Patients on Biological Treatment
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Evaluation of Blood Platelet Indices, Platelet Aggregation and Coagulation Profile in the Activity State of Inflammatory Bowel Disease Patients on Biological Treatment
Status: UNKNOWN
Status Verified Date: 2022-06
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: ulcerative colitis and Crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. The mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors
Detailed Description: Histopathological examinations play a role in the diagnosis and management of UC, but they are costly and invasive. So, non-invasive inflammatory biomarkers of IBD, such as the WBCS, ESR and CRP are used in clinical practice .

Platelets play a critical role in blood hemostasis so impaired platelet activation may cause persistent mucosal inflammation. Many studies have demonstrated that patients with IBD may have increased risks of venous thrombosis. Thrombosis is a major cause of morbidity and mortality in IBD.

Platelet to lymphocyte ratio can be easily calculated from CBC can serve as useful biomarkers for predicting mucosal inflammation in UC.

Current disease management guidelines were focused on the use of anti-inflammatory agents, aminosalicylates, and corticosteroids. However, some patients are still refractory to these therapies.

Biological therapy has revolutionized the management of inflammatory bowel disease in the last few years. There available biologic medicines are infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. Biological therapy brought a better control of inflammatory bowel diseases. Its use requires specific care before the beginning and during the treatment.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: