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The aim of the study is to evaluate the effectiveness and safety of the application of pathogen inactivated RBC suspension in children with oncological and hematological diseases.
Assumed scope of study:
The study will include 70 patients: 35 patients to the test group, who will get transfusions with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who will get transfusions with irradiated red blood cell suspension.
Methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riboflavin+UV RBC | Experimental | 35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology |
|
| irradiated RBC | Active Comparator | 35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin+UV RBC | Biological | 35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology |
| Measure | Description | Time Frame |
|---|---|---|
| post-transfusion reactions | evaluate the presence and severity of post-transfusion reactions and complications. | 24 hours after transfusion |
| augmentation of hemoglobin | Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion | 24 hours after transfusion |
| augmentation of hematocrit | Measure the patient's hematocrit (%) the next day after the transfusion | 24 hours after transfusion |
| immune responses | Perform direct antiglobuline test | 3-5 days after transfusion |
| sensitization | perform indirect antiglobuline test | 2-3 weeks after transfusion |
| intertransfusion interval | Evaluate the need for transfusions over the follow-up period (30 days) | 1 months |
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Inclusion Criteria:
Patients who need supportive transfusion therapy with RBC suspension
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavel Trakhtman, PhD | Federal Research Center for pediatric hematology, oncology and immunology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Research Center for pediatric hematology, oncology and immunology | Moscow | 117997 | Russia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 14, 2020 | |
| Reset | Jul 28, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2020 | Jul 28, 2020 |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| irradiated RBC | Biological | 35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension |
|