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.

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Key information

Conditions

Hemophagocytic Syndrome Hemic and Lymphatic Diseases Histiocytosis Histiocytosis, Non-Langerhans-Cell Lymphatic Diseases Lymphohistiocytosis, Hemophagocytic

Sex eligibility

All sexes

Study type

Observational

Primary location

Affilitated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

Location status: Recruiting

Location contact

Wei Sang, Docter

CONTACT

[email protected]

13645207648

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the following criteria:

Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step
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

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

Treatment and study plan

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

Drug

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

Primary outcomes

The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.

Time frame: Time forecasting:2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Sang, Doctor

CONTACT

[email protected]

13645207648

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 26, 2024
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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