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

Launched by THE THIRD PEOPLE'S HOSPITAL OF CHENGDU · Aug 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called Hetrombopag for patients who have low platelet counts, a condition known as thrombocytopenia, before they undergo elective surgery. The trial aims to see if this treatment can help raise platelet levels to reduce the risk of bleeding during surgery. It is currently recruiting participants who are at least 18 years old and have been diagnosed with immune thrombocytopenia, specifically those whose platelet counts are below 75,000 per microliter of blood.

To be eligible for this trial, participants should not have a history of severe allergic reactions to similar medications, serious bleeding issues, certain blood clotting diseases, or other specific health conditions. Those who participate can expect regular monitoring and follow-up during the study to assess how well the treatment is working and if there are any side effects. This trial is important because it could lead to better management options for patients facing surgery with low platelet counts, helping to improve their safety and outcomes.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old; diagnosis of immune thrombocytopenia.
• • 2. Platelets ≤75×10\^9/L before scheduled elective surgery.
• Exclusion Criteria:
• • 1. History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
• • 2. Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
• • 3. Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
• • 4. Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
• • 5. New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
• • 6. History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
• • 7. Have an active infection that is difficult to control;
• • 8. Pregnant or lactating women;
• • 9. Other conditions determined by the investigator to be unsuitable for inclusion in the study