Thrombocytopenia
Conditions
Keywords
Hetrombopag, Thrombocytopenia, Preoperative
Brief 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
Detailed description
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.
Interventions
DRUGHetrombopag
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.
Sponsors
Affiliated Hospital of North Sichuan Medical College
The Third People's Hospital of Chengdu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet elevation | up to 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome | up to 14 days | The median time to reach the platelet count target; |
Countries
China
Contacts
Primary ContactYing Li, PhD
Backup ContactZuofeng Liu, Master
Outcome results
None listed