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Evaluate the efficacy and safety of various treatment schemes for severe fever with thrombocytopenia syndrome: a prospective, multicenter, non-randomized control intervention study

SFTS-UMBRELLA STUDY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062874
Enrollment
Unknown
Registered
2022-08-22
Start date
2022-08-22
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SFTS

Interventions

Intervention group (part A-part C):Part a: on the basis of routine treatment, the patients in group a received methylprednisolone 2 mg/kg/D IVIG 20 g/D for a total of 5 days. If the disease progresses
Non intervention group (routine treatment group):Standard treatment regimen, 14 days in total

Sponsors

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, gender is not limited; 2. Meet the following diagnostic criteria for fever with thrombocytopenia syndrome: Patients with positive SFTs virus (sftsv) in peripheral blood detected by RT-PCR or next generation sequencing (NGS); 3. The intervention group shall meet the following conditions: Part A: If the patient has 2 of the following conditions, the treatment can be started: (1) Continuous high fever for 7 days or more; (2) Platelets 2 times the upper limit of normal value (ULN); Part C: Plasma D-D dimer >= 4xUL; 4. Sign written informed consent and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with tumor diseases; 2. Patients with serious chronic diseases, such as chronic kidney disease (stage 3-5), chronic heart failure, decompensated cirrhosis, chronic diseases of the central nervous system, blood tumor diseases, uncontrolled solid tumors, etc.; 3. Patients who are pregnant or may be pregnant; 4. Patients with a history of hypersensitivity to the investigational drug and its components; 5. The investigator judges that the patients with diseases affecting the short-term survival rate are not suitable for inclusion in this protocol; Among them, the additional exclusion criteria of Part B group:Platelets 2.0, or thromboelastogram results suggest obvious fibrinolysis. 6. Other clinically obvious forms of shock occur, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic or anaphylactic shock.

Design outcomes

Secondary

MeasureTime frame
Biological samples;

Countries

China

Contacts

Public ContactNing Qin

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

qning@vip.sina.com13971521450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026