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

Last updated: September 27, 2024
Sponsor: The Affiliated Hospital of Xuzhou Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Histiocytoma

Treatment

Patients diagnosed with HLH-94 should be treated as soon as possible

Clinical Study ID

NCT06614998
XYFY2024-KL100-01
  • All Genders

Study Summary

Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must meet all of the following criteria:

  1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicatorsin the second step

  2. Patients who meet the first step screening + have 2 abnormal screening indicators inthe second step + patients with high-risk factors for HLH, such as history oflymphoma, EBV infection, autoimmune diseases, etc

Exclusion

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

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Patients diagnosed with HLH-94 should be treated as soon as possible
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
May 01, 2026

Connect with a study center

  • Affilitated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221006
    China

    Active - Recruiting

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