Clinical trial · Interventional
Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia
Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study
NCT03195010CI-TRIAL-00041217terminatedPhase 2Results postedClinicalTrials.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): Terminated because of slow recruitment and lack of funding support
Summary
Brief summary (as posted)
This pilot clinical trial compares the safety of two different platelet transfusion "thresholds" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Biphenotypic Leukemia | Acute Biphenotypic Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| B-Cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Hematologic and Lymphocytic Disorder | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Platelet Transfusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (lower dose platelet transfusion)
- description
- Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 30 x 10\^9/L for up to 30 days or until the platelet count spontaneously recovers to \> 50 x 10\^9 for 3 consecutive days in the absence of transfusions.
- interventionNames
- Biological: Platelet Transfusion
- type
- EXPERIMENTAL
- label
- Group II (higher dose platelet transfusion)
- description
- Patients undergo platelet transfusion on all days when the morning platelet count is below the threshold 50 x 10\^9/L for up to 30 days or until the platelet count spontaneously recovers to \> 50 x 10\^9 for 3 consecutive days in the absence of transfusions.
- interventionNames
- Biological: Platelet Transfusion
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], biphenotypic leukemia) undergoing curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as above, chronic myelogenous leukemia \[CML\], chronic lymphocytic leukemia \[CLL\], myelodysplastic syndrome \[MDS\], primary or secondary myelofibrosis, hypereosinophilic syndromes, plasma cell disorders, B-cell or T-cell lymphoma) * Disease may be measurable or non-measurable * Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose anticoagulation (unfractionated or low-molecular weight heparin or oral anticoagulants) throughout the period of hematopoietic recovery * Anticipated platelet count =\< 50 x 10\^9/L for \>= 5 days within 72 hours of enrollment * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Separate episode of VTE or arterial thrombosis within 3 months of enrollment * Major bleed (WHO grade 3 or 4) within 6 months of enrollment * Active bleeding (grade 2 or higher) at the time of enrollment * History of intracranial bleeding at any time * Disorders of hemostasis including von Willebrand disease, hemophilia, platelet function disorders * Concomitant use of aspirin or non-steroidal anti-inflammatory drugs * Evidence of disseminated intravascular anticoagulation (DIC) as determined by the patient's primary provider * History of alloimmunization (defined as platelet refractoriness with panel reactive antibody \[PRA\] \> 25%) at the time of or prior to enrollment * Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris * Psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or able to become pregnant and unwilling to use two forms of birth control during the study period
References
Publications (0)
Data not yet available
No reference posted for this study.