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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemophagocytic Syndrome
• Intervention / Treatment: Drug: Patients diagnosed with HLH-94 should be treated as soon as possible

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Wei Sang, Doctor; Phone Number: 13645207648; Email: sw1981726@126.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221006
      • Recruiting
      • Affilitated Hospital of Xuzhou Medical University
      • Contact: Wei Sang, Docter; Phone Number: 13645207648; Email: sw1981726@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A three-step screening process identified 80 people with suspected hemophagocytic syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Screening patients with suspected hemophagocytic syndrome; Preliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome

Drug: Patients diagnosed with HLH-94 should be treated as soon as possible; For some highly suspicious patients, after diagnosis, according to the patient's etiology, the treatment plan should be determined as soon as possible, such as lymphoma-related patients treated with hormones combined with etoposide, which can greatly improve the prognosis of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.	Time forecasting:2 years

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: hemophagocytic syndrome screening system
• Additional Relevant MeSH Terms: Lymphatic Diseases; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphohistiocytosis, Hemophagocytic
• Other Study ID Numbers: XYFY2024-KL100-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No