Evaluating Hetrombopag for Patients with Low Platelets Before Surgery
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
This study is testing if a new medication called Hetrombopag can safely raise platelet levels in patients with low platelets before they have surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Third People's Hospital of Chengdu Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06562738 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the efficacy and safety of Hetrombopag in patients with immune thrombocytopenia who have low platelet counts before elective surgery. It will include 55 participants who will receive a daily oral dose of Hetrombopag for up to 14 days, with platelet levels monitored regularly. The treatment will continue until platelet counts reach a safe level for surgery, ensuring patient safety and readiness for the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with immune thrombocytopenia and having platelet counts of 75×10^9/L or lower before surgery.
Not a fit: Patients with a history of severe bleeding, thrombotic diseases, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve surgical outcomes for patients with thrombocytopenia by safely increasing platelet counts.
How similar studies have performed: While there have been studies on thrombopoietin receptor agonists, the specific use of Hetrombopag in this preoperative context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chengdu, Sichuan
- Chengdu Third People's Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Jing Tan, Md — 成都市第三人民医院
- Study coordinator: Ying Li, PhD
- Email: 79468064@qq.com
- Phone: +86 028 61318717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.