The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial)
Abstract Background Sepsis is still a common critical disease with high morbidity and mortality in intensive care unit. Despite published guidelines for sepsis, development of antibiotic therapy and advanced organ support technologies, the mortality of sepsis patients is still 25% or more. It is nec...
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| Format: | Article |
| Language: | English |
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BMC
2019-09-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | http://link.springer.com/article/10.1186/s12879-019-4388-2 |
| _version_ | 1818911071889522688 |
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| author | Zhigang Zhou Tienan Feng Yun Xie Peijie Huang Hui Xie Rui Tian Biyun Qian Ruilan Wang |
| author_facet | Zhigang Zhou Tienan Feng Yun Xie Peijie Huang Hui Xie Rui Tian Biyun Qian Ruilan Wang |
| author_sort | Zhigang Zhou |
| collection | DOAJ |
| description | Abstract Background Sepsis is still a common critical disease with high morbidity and mortality in intensive care unit. Despite published guidelines for sepsis, development of antibiotic therapy and advanced organ support technologies, the mortality of sepsis patients is still 25% or more. It is necessary to distinguish the subtypes of sepsis, and the targeted therapy for the patients need to be explored. Platelets have various biological functions in hemostasis and thrombosis, host defense, inflammatory/immune responses and tissue repair/regeneration. Moreover, severe thrombocytopenia or sustained thrombocytopenia was closely associated with multiply organ dysfunction and higher mortality in sepsis patients. The clinical therapies for thrombocytopenia are platelet transfusion and platelet-elevating drugs. However, platelet transfusion has many defects in clinical practice in sepsis patients, and the impact of platelet-elevating drugs for sepsis patients is still unclear. RESCUE trial is aim to explore the effect of a platelet-elevating drug, recombinant human thrombopoietin (rhTPO), as an effective rescue therapy on sepsis patients with acute severe thrombocytopenia. Methods It is a randomized, open-label, multi-center, controlled trial in 5 tertiary academic hospitals including medical, surgical or general ICUs. In this study, a total of 200 sepsis patients with severe thrombocytopenia will be randomly assigned in a 1:1 ratio to the control and rhTPO group. The patients will be followed up to 28 days after randomization. All patients in two groups receive the same treatment based on the guideline of Surviving Sepsis Campaign. Primary outcome is 28-day mortality. Secondary outcomes are the changes of PCs, blood transfusion, biomarkers of infection and organ function, days free from advanced organ support, drug-related adverse events, the length of ICU and hospital stay. Discussion RESCUE trial is the first randomized controlled trial to explore the impact of rhTPO for severe thrombocytopenia in sepsis patients diagnosed by sepsis-3.0 standard. Furthermore, RESCUE trial results will be of significant clinical value on the targeted therapy and add clinical evidence that rhTPO is an effective rescue therapy for these sepsis patients. Trial registration ClinicalTrials.gov: NCT02707497. Registered Date: March 3rd, 2016. Protocol Version 3. Protocol Date: January 25th, 2019. |
| first_indexed | 2024-12-19T22:52:53Z |
| format | Article |
| id | doaj.art-6844fcf2c913404e92084c9f1a9ea4bf |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-12-19T22:52:53Z |
| publishDate | 2019-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-6844fcf2c913404e92084c9f1a9ea4bf2022-12-21T20:02:43ZengBMCBMC Infectious Diseases1471-23342019-09-011911710.1186/s12879-019-4388-2The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial)Zhigang Zhou0Tienan Feng1Yun Xie2Peijie Huang3Hui Xie4Rui Tian5Biyun Qian6Ruilan Wang7Department of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityClinical Research Institute, Shanghai Jiaotong University School of MedicineDepartment of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityDepartment of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityDepartment of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityDepartment of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityClinical Research Institute, Shanghai Jiaotong University School of MedicineDepartment of Critical Care Medicine, Shanghai General Hospital of Nanjing Medical UniversityAbstract Background Sepsis is still a common critical disease with high morbidity and mortality in intensive care unit. Despite published guidelines for sepsis, development of antibiotic therapy and advanced organ support technologies, the mortality of sepsis patients is still 25% or more. It is necessary to distinguish the subtypes of sepsis, and the targeted therapy for the patients need to be explored. Platelets have various biological functions in hemostasis and thrombosis, host defense, inflammatory/immune responses and tissue repair/regeneration. Moreover, severe thrombocytopenia or sustained thrombocytopenia was closely associated with multiply organ dysfunction and higher mortality in sepsis patients. The clinical therapies for thrombocytopenia are platelet transfusion and platelet-elevating drugs. However, platelet transfusion has many defects in clinical practice in sepsis patients, and the impact of platelet-elevating drugs for sepsis patients is still unclear. RESCUE trial is aim to explore the effect of a platelet-elevating drug, recombinant human thrombopoietin (rhTPO), as an effective rescue therapy on sepsis patients with acute severe thrombocytopenia. Methods It is a randomized, open-label, multi-center, controlled trial in 5 tertiary academic hospitals including medical, surgical or general ICUs. In this study, a total of 200 sepsis patients with severe thrombocytopenia will be randomly assigned in a 1:1 ratio to the control and rhTPO group. The patients will be followed up to 28 days after randomization. All patients in two groups receive the same treatment based on the guideline of Surviving Sepsis Campaign. Primary outcome is 28-day mortality. Secondary outcomes are the changes of PCs, blood transfusion, biomarkers of infection and organ function, days free from advanced organ support, drug-related adverse events, the length of ICU and hospital stay. Discussion RESCUE trial is the first randomized controlled trial to explore the impact of rhTPO for severe thrombocytopenia in sepsis patients diagnosed by sepsis-3.0 standard. Furthermore, RESCUE trial results will be of significant clinical value on the targeted therapy and add clinical evidence that rhTPO is an effective rescue therapy for these sepsis patients. Trial registration ClinicalTrials.gov: NCT02707497. Registered Date: March 3rd, 2016. Protocol Version 3. Protocol Date: January 25th, 2019.http://link.springer.com/article/10.1186/s12879-019-4388-2SepsisThrombopoietinSevere thrombocytopeniaMortalityRescue therapy |
| spellingShingle | Zhigang Zhou Tienan Feng Yun Xie Peijie Huang Hui Xie Rui Tian Biyun Qian Ruilan Wang The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) BMC Infectious Diseases Sepsis Thrombopoietin Severe thrombocytopenia Mortality Rescue therapy |
| title | The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) |
| title_full | The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) |
| title_fullStr | The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) |
| title_full_unstemmed | The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) |
| title_short | The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial (RESCUE trial) |
| title_sort | effect of recombinant human thrombopoietin rhtpo on sepsis patients with acute severe thrombocytopenia a study protocol for a multicentre randomised controlled trial rescue trial |
| topic | Sepsis Thrombopoietin Severe thrombocytopenia Mortality Rescue therapy |
| url | http://link.springer.com/article/10.1186/s12879-019-4388-2 |
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