Early warning screening system for hemophagocytic lymphohistiocytosis

Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study

This study is testing a new screening system to help doctors quickly find patients at high risk for hemophagocytic lymphohistiocytosis (HLH) so they can start treatment sooner and improve their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Sex: All
• Sponsor: The Affiliated Hospital of Xuzhou Medical University (Academic / other)
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT06614998 on ClinicalTrials.gov

What this trial studies

This study aims to establish a three-step screening system that utilizes common clinical and laboratory parameters to identify patients at high risk for hemophagocytic lymphohistiocytosis (HLH). The approach involves early etiology screening for patients who meet the diagnostic criteria for HLH and guiding standardized treatment based on identified high-risk factors. By improving early diagnosis and treatment success rates, the study seeks to enhance the quality of life for affected patients.

Who should consider this trial

Good fit: Ideal candidates include patients who meet the initial screening criteria and exhibit abnormal indicators or high-risk factors for HLH.

Not a fit: Patients with severe underlying conditions such as liver cirrhosis, trauma, or those on immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this system could significantly improve early diagnosis and treatment outcomes for patients at risk of hemophagocytic syndrome.

How similar studies have performed: While this approach is novel, similar studies focusing on early diagnosis and screening systems have shown promise in other conditions.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
2. Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc

Exclusion Criteria:

Exclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones/immunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency

Where this trial is running

Xuzhou, Jiangsu

• Affilitated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wei Sang, Doctor

Conditions Hemophagocytic Syndrome; hemophagocytic syndrome screening system