Document Detail

A safety evaluation of drotrecogin alfa (activated) in hematopoietic stem cell transplant patients with severe sepsis: lessons in clinical research.
MedLine Citation:
PMID:  16086043     Owner:  NLM     Status:  MEDLINE    
We conducted an open-label, multicenter, single-arm clinical trial to investigate the safety and efficacy of drotrecogin alfa (activated) (Drot AA) in hematopoietic stem cell transplant (HSCT) patients with severe sepsis. Drot AA was administered as a continuous i.v. infusion of 24 microg/kg/h for 96 h. The target enrollment was 250 patients in 15-20 transplant centers over a 2-year period (March 2003-March 2005). However, after only 10 months, in December 2003, the trial was stopped due to a low enrollment of seven patients at three of the 15 sites that were open for accrual. Six of the seven patients completed the drug infusion. Two patients experienced serious bleeding events. The first patient developed a nonfatal diffuse alveolar hemorrhage 2 days after study-drug completion. The second patient had severe coagulopathy and developed a fatal intracranial hemorrhage on the third day of drug infusion. Three of the seven patients were alive 100 days after the HSCT. The slow enrollment rate was attributed to changes in transplant preparatory regimens, enhancements in antimicrobial prophylactic protocols and the use of antimicrobial-coated catheters. The small number of patients in this report precludes a definitive assessment of the safety and efficacy of Drot AA in HSCT patients.
S M Pastores; A Shaw; M D Williams; E Mongan; M Alicea; N A Halpern
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Bone marrow transplantation     Volume:  36     ISSN:  0268-3369     ISO Abbreviation:  Bone Marrow Transplant.     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-03     Completed Date:  2005-11-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8702459     Medline TA:  Bone Marrow Transplant     Country:  England    
Other Details:
Languages:  eng     Pagination:  721-4     Citation Subset:  IM    
Department of Anesthesiology and Critical Care Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
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MeSH Terms
Anti-Infective Agents / therapeutic use*
Leukemia / therapy
Lymphoma / therapy
Middle Aged
Protein C / standards,  therapeutic use*
Recombinant Proteins / standards,  therapeutic use
Sepsis / drug therapy*,  etiology*
Stem Cell Transplantation / adverse effects*
Reg. No./Substance:
0/Anti-Infective Agents; 0/Protein C; 0/Recombinant Proteins; 0/drotrecogin alfa activated
Comment In:
Bone Marrow Transplant. 2006 Oct;38(8):575-6   [PMID:  16921401 ]

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