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To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.
This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Remind patients to test their immune status among 120-180 days post-transplantation. Physicians assessed the risk level of patients in the intervention group based on their immune status on days 91-180 using the CIRS. |
|
| Control group | No Intervention | Only remind patients to test their immune status among 120-180 days post-transplantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health monitoring and regular return follow-up reminders | Behavioral | Health monitoring & reminders for blood tests and follow-up visits until 1 year post-transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Overall survival during 1.5 years after transplantation | 1.5 years after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse mortality rate | Non-relapse mortality rate during 1.5 years after transplantation | 1.5 years after transplantation |
| Incidence of infections | Infections during 1.5 years after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahui Feng, MS | Contact | 022-23909051 | fengyahui@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2024 | Mar 28, 2024 |
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| 1.5 years after transplantation |
| Immune cell count | Data on immune cell count will be collected during 1.5 years after transplantation | 1.5 years after transplantation |
| Prot_001.pdf |