Thrombotic Disorder Clinical Trial
Official title:
The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation
We aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.
Status | Not yet recruiting |
Enrollment | 260 |
Est. completion date | December 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Aged 16-70 years old 2. Diagnosed as myeloid malignancies, and about to undergo allo-HSCT; 3. ECOG: 0-2; 4. Expected survival longer than 1 month Exclusion Criteria: 1. Allergic to any components of NAC; 2. Severe dysfunction of heart, liver, lung and kidney; 3. Relapse before HSCT; 4. A history of bronchial asthma, bronchospasm or moderate / severe gastrohelcosis. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The First Affiliated Hospital of Soochow University |
Carreras E, Diaz-Beya M, Rosinol L, Martinez C, Fernandez-Aviles F, Rovira M. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood Marrow Transplant. 2011 Nov;17(11):1713-20. doi: 10.1016/j.bbmt.2011.06.006. Epub 2011 Jun 25. — View Citation
Coppell JA, Richardson PG, Soiffer R, Martin PL, Kernan NA, Chen A, Guinan E, Vogelsang G, Krishnan A, Giralt S, Revta C, Carreau NA, Iacobelli M, Carreras E, Ruutu T, Barbui T, Antin JH, Niederwieser D. Hepatic veno-occlusive disease following stem cell transplantation: incidence, clinical course, and outcome. Biol Blood Marrow Transplant. 2010 Feb;16(2):157-68. doi: 10.1016/j.bbmt.2009.08.024. Epub 2009 Sep 18. — View Citation
George JN, Li X, McMinn JR, Terrell DR, Vesely SK, Selby GB. Thrombotic thrombocytopenic purpura-hemolytic uremic syndrome following allogeneic HPC transplantation: a diagnostic dilemma. Transfusion. 2004 Feb;44(2):294-304. doi: 10.1111/j.1537-2995.2004.00700.x. — View Citation
Ho VT, Cutler C, Carter S, Martin P, Adams R, Horowitz M, Ferrara J, Soiffer R, Giralt S. Blood and marrow transplant clinical trials network toxicity committee consensus summary: thrombotic microangiopathy after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2005 Aug;11(8):571-5. doi: 10.1016/j.bbmt.2005.06.001. — View Citation
Jodele S, Laskin BL, Dandoy CE, Myers KC, El-Bietar J, Davies SM, Goebel J, Dixon BP. A new paradigm: Diagnosis and management of HSCT-associated thrombotic microangiopathy as multi-system endothelial injury. Blood Rev. 2015 May;29(3):191-204. doi: 10.1016/j.blre.2014.11.001. Epub 2014 Nov 28. — View Citation
Labrador J, Lopez-Anglada L, Perez-Lopez E, Lozano FS, Lopez-Corral L, Sanchez-Guijo FM, Vazquez L, Perez Rivera JA, Martin-Herrero F, Sanchez-Barba M, Guerrero C, del Canizo MC, Caballero MD, San Miguel JF, Alberca I, Gonzalez-Porras JR. Analysis of incidence, risk factors and clinical outcome of thromboembolic and bleeding events in 431 allogeneic hematopoietic stem cell transplantation recipients. Haematologica. 2013 Mar;98(3):437-43. doi: 10.3324/haematol.2012.069559. Epub 2012 Aug 16. — View Citation
Laskin BL, Goebel J, Davies SM, Jodele S. Small vessels, big trouble in the kidneys and beyond: hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Blood. 2011 Aug 11;118(6):1452-62. doi: 10.1182/blood-2011-02-321315. Epub 2011 May 19. — View Citation
Sartain S, Shubert S, Wu MF, Srivaths P, Teruya J, Krance R, Martinez C. Therapeutic Plasma Exchange does not Improve Renal Function in Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy: An Institutional Experience. Biol Blood Marrow Transplant. 2019 Jan;25(1):157-162. doi: 10.1016/j.bbmt.2018.08.016. Epub 2018 Aug 23. — View Citation
Tsirigotis PD, Resnick IB, Avni B, Grisariu S, Stepensky P, Or R, Shapira MY. Incidence and risk factors for moderate-to-severe veno-occlusive disease of the liver after allogeneic stem cell transplantation using a reduced intensity conditioning regimen. Bone Marrow Transplant. 2014 Nov;49(11):1389-92. doi: 10.1038/bmt.2014.168. Epub 2014 Jul 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | The incidence of thrombotic disorders | The incidence of thrombotic disorders (TA-TMA, SOS, DVT, PTE, CRT, SVT) after allogenic hematopoietic stem cell transplantation | 1 year | |
Primary | Overall survival | The rate of overall survival after allogenic hematopoietic stem cell transplantation | 1 year | |
Secondary | The incidence of relapse | The incidence of relapse after allogenic hematopoietic stem cell transplantation | 1 year | |
Secondary | The incidence of GVHD | The incidence of GVHD after allogenic hematopoietic stem cell transplantation | 1 year | |
Secondary | The incidence of hematopoietic reconstitution | The incidence of hematopoietic reconstitution after allogenic hematopoietic stem cell transplantation | 1 year |
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