About this trial
This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old; diagnosis of immune thrombocytopenia.
Platelets ≤75×10^9/L before scheduled elective surgery.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Hetrombopag
DrugHetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10\^9/L, and take blood routine examination weekly, drug administration was resumed when PLT \< 100 ×10\^9/L. When PLT ≤30× 10\^9/L or ≥300 ×10\^9/L, take blood routine examination every 3 days.
Treatment groups
Trial outcomes
Primary outcomes
Platelet elevation
Proportion of patients achieving perioperative platelet count goals (≥80×10\^9/ L for major surgery and ≥50×10\^9/ L for minor surgery) without emergency treatment
Secondary outcomes
Secondary Outcome
The median time to reach the platelet count target;
Sponsors and contacts
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The Third People's Hospital of Chengdu
Lead sponsor
Affiliated Hospital of North Sichuan Medical College
Collaborator