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To assess the efficacy and safety of lusutrombopag combined with recombinant human thrombopoietin for the treatment of thrombocytopenia in patients with chronic liver disease destined to undergo elective invasive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Lusutrombopag combined with recombinant human thrombopoietin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lusutrombopag combined with recombinant human thrombopoietin | Drug | After eligibility is confirmed, patients will begin treatment with Lusutrombopag +recombinant human thrombopoietin on Day 1, and study treatment will continue for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of respondents at day 8 | Responders were defined as subjects who achieved a platelet count of ≥50 × 10^9/L and an increase of ≥20 × 10^9/L from baseline and who did not receive emergency treatment for bleeding | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery | Proportion of subjects achieving a platelet count ≥50 × 10^9/L on or after day 8 and within 2 days prior to elective invasive surgery | on or after day 8 and within 2 days prior to elective invasive surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-Zhou Wang | Contact | +86 13836135864 | wangjoe@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lianxin Liu | Anhui Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 People's Hospital of Fuyang city | Recruiting | Fuyang | Anhui | 236015 | China |
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| Proportion of subjects meeting the definition of responder at any time during the study period |
Responders were defined as subjects who achieved a platelet count of ≥50 × 10^9/L and an increase of ≥20 × 10^9/L from baseline and who did not receive emergency treatment for bleeding |
| Each routine blood test on or after day 8 |
| Proportion of subjects requiring emergency treatment for bleeding at any time during the study period | Proportion of subjects requiring emergency treatment for bleeding at any time during the study period | During the procedure |
| Number and dose of platelet transfusions during the study period | Number and dose of platelet transfusions during the study period | During the procedure |
| Anhui province hospital | Recruiting | Hefei | Anhui | 230000 | China |
|
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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