A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

Criteria

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.