Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation.
This study employs a prospective, randomized, double-blind, placebo-controlled design. It aims to compare the efficacy of etamsylate versus placebo in preventing bleeding complications in patients with thrombocytopenia following hematopoietic stem cell transplantation. The primary endpoint is the incidence of death or bleeding events (WHO grade ≥2) within 30 days. Secondary endpoints focus on the safety profile of etamsylate versus placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etamsylate | Experimental | Etamsylate Injection: Administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily. |
|
| placebo | Placebo Comparator | 0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etamsylate | Drug | etamsylate Injection, administer by intravenous infusion, diluted with 100ml of 0.9% Sodium Chloride Injection, twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| WHO grade 2 or higher bleeding events or death. | The incidence of WHO grade 2 or higher bleeding events or death within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the incidence in the experimental group is 14.2% lower than that in the placebo group. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days without WHO grade 2 or higher bleeding events | The number of days without WHO grade 2 or higher bleeding events within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the number of days without WHO grade 2 or higher bleeding events is 2 days more in the experimental group than in the placebo group. | 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Luo | Contact | 86-13666609126 | luoyijr@zju.edu.com | |
| Luxin Yang | Contact | 86-13588756650 | yangluxin2016@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Luo | The First Affiliated Hospital, College of Medicine, Zhejiang University Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| D004979 | Ethamsylate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 0.9% Sodium Chloride Injection, 100 ml, twice daily, intravenous drip |
|
| The number of platelet transfusions | The number of platelet transfusions within 30 days of medication administration. Etamsylate will be considered effective compared to placebo when the number of platelet transfusions in the experimental group is 2.5 fewer than in the placebo group. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |