Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Infection, Sepsis
Conditions
Brief summary
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
Detailed description
The purpose of this study is to determine how Drotrecogin Alfa (activated) will affect leukemia, lymphoma and myeloma patients who develop sever sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT). The study will evaluate the safety of Xigris by assessing the risk of serious bleeding events, including bleeding within the brain and serious bleeding leading to death.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have Leukemia, Lymphoma or Myeloma. * Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days. * Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure. * Participants must be on a breathing machine or require medication to maintain their blood pressure.
Exclusion criteria
* Participants must not have increased bleeding risk due to medical conditions or medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | 10 months |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | 10 months |
| Bleeding incidence | 10 months |
Countries
United States
Outcome results
None listed