Clinical trial · Interventional
A Safety Evaluation of Drotrecogin Alfa (Activated) in Patients With Blood Cancer, Severe Infection Related to Bone Marrow Transplantation
A Safety Evaluation of Xigris Drotrecogin Alfa Activated in Hematopoietic Stem Cell Transplant Patients With Severe Sepsis
NCT00067730CI-TRIAL-00001014completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Sepsis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drotrecogin Alfa (activated) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 24 microgram/kg/hr for 96 hours (+ or - 1 hour)
- interventionNames
- Drug: Drotrecogin Alfa (activated)
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 10 months
Secondary outcomes (2)
- measure
- Mortality
- timeFrame
- 10 months
- measure
- Bleeding incidence
- timeFrame
- 10 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.