Clinical trial · Interventional
Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study
NCT03086252CI-TRIAL-00034004withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This pilot study evaluates safety of administration of red blood cell transfusions requested by patients based on their symptoms instead of levels of hemoglobin for the treatment of chronic anemia in patients with blood disorders.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Aplastic Anemia | — | UNRESOLVED | — |
| Bone Marrow Failure | — | UNRESOLVED | — |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Red Blood Cell Transfusions (RBCT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (patient-driven RBCT)
- description
- Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months.
- interventionNames
- Procedure: Red Blood Cell Transfusions (RBCT)
Primary outcomes (1)
- measure
- Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03.
- timeFrame
- Up to 6 months of study participation
- description
- Frequency, duration, and severity of AEs and severe adverse events will be determined. The proportion of subjects with serious side effects will be calculated with 95% confidence interval. Descriptive statistics will be used to characterize subjects enrolled on the trial: age, sex, race and diagnosis.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with hematological malignancy or marrow failure syndrome such as but not limited to: aplastic anemia, myelodysplastic syndrome or leukemia * Chronic transfusion-dependent anemia with exposure to at least 5 RBCT * Interested in reducing transfusion exposure * Willing to sign informed consent Exclusion Criteria: * Recent acute bleeding requiring intervention in less than 24 hours * Hemoglobin levels \< 6 g/dL * Acute leukemia receiving induction chemotherapy * Any patient with known ischemic heart disease, history of congestive heart failure, history of stroke, or cardiac arrhythmia for which the patient requires medication or a medical device * Oxygen dependent * Oxygen saturation below 92% on room air * Receiving erythropoietin stimulating agent * Thalassemia major or sickle cell disease requiring blood transfusion * Undergoing major surgery * Hemolytic anemia * Coagulopathies including disseminated intravascular coagulation (DIC), receiving anticoagulant or antiplatelet agents * Diagnosed with chronic obstructive pulmonary disease (COPD) oxygen dependent * Pregnancy * Participation in a therapeutic clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.