Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10^9/L, and continued when the blood image was monitored weekly until PLT < 100×10^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10^9/L or ≥300×10^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.

Inclusion criteria

• Age ≥18 years old; diagnosis of immune thrombocytopenia.
• Platelets ≤75×10^9/L before scheduled elective surgery.

Exclusion criteria

• History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
• Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
• Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
• Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
• New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
• History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
• Have an active infection that is difficult to control;
• Pregnant or lactating women;
• Other conditions determined by the investigator to be unsuitable for inclusion in the study