Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
The Third People's Hospital of Chengdu
55 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria2
- Age ≥18 years old; diagnosis of immune thrombocytopenia.
- Platelets ≤75×10\^9/L before scheduled elective surgery.
Exclusion Criteria9
- 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
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Interventions
Hetrombopag 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06562738