Actively Recruiting
Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study
Led by The Affiliated Hospital of Xuzhou Medical University · Updated on 2024-10-01
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are developing a three-step early warning system to better identify patients at high risk for hemophagocytic lymphohistiocytosis (HLH). This observational study aims to improve early diagnosis and guide precise treatment by screening patients who meet HLH diagnostic criteria and identifying underlying causes and risk factors such as lymphoma, EBV infection, and autoimmune diseases. The goal is to increase treatment success rates and enhance patients' quality of life. The screening process begins with evaluating common clinical and laboratory markers like elevated ferritin and low fibrinogen. Further assessments include triglyceride levels and abdominal ultrasound, with advanced tests such as genetic analysis and NK cell activity for highly suspicious cases. Patients diagnosed following the HLH-94 protocol receive timely treatment tailored to their underlying cause, for example, combining hormones with etoposide for lymphoma-related HLH. Participants undergo screening and diagnostic tests to confirm HLH, including NK cell activity and triglyceride measurements, over a follow-up period of two years. The study monitors the effectiveness of early identification and treatment guidance through these assessments. This approach aims to detect suspected HLH patients early and support standardized, targeted therapies to improve outcomes.
CONDITIONS
Brief Title
Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who meet the first step screening plus have 3 or more abnormal screening indicators in the second step
- Patients who meet the first step screening plus have 2 abnormal screening indicators in the second step plus high-risk factors for HLH such as history of lymphoma, EBV infection, or autoimmune diseases
You will not qualify if you...
- Patients with liver cirrhosis, liver cancer, or hepatic encephalopathy
- Patients with trauma, hepatosplenic rupture, or other organ hemorrhage
- Patients with severe disease such as shock, sepsis, or multiple organ failure
- Patients with disseminated intravascular coagulation (DIC)
- Patients with long-term anemia
- Patients with acute promyelocytic leukemia
- Patients with idiopathic deafness
- Patients who have taken hormones or immunosuppressants within 72 hours before admission
- Patients with hereditary fibrinogen deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks as needed
Participants with elevated ferritin and low fibrinogen undergo further tests such as triglycerides, abdominal ultrasound, gene tests, and NK cell activity assessments to determine if they have hemophagocytic syndrome.
1 to 2 visits depending on test requirements
Duration - Up to 2 years
Participants diagnosed with hemophagocytic syndrome are observed over time for disease progression and response to treatment.
Periodic visits as determined by clinical need
Trial Site Locations
Total: 1 location
1
Affilitated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
Research Team
W
Wei Sang, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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