Clinical trial · Observational
Bleeding In Thrombocytopenia Explained
Bleeding in Thrombocytopenia Explained
NCT03505086CI-TRIAL-00072451BITEunknownClinicalTrials.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)
Multicenter case cohort study investigating clinical risk factors for clinically relevant bleeding in hemato-oncology patients, as well as bleeding related biomarkers during intensive treatment.
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 |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hemorrhage | — | UNRESOLVED | — |
| Platelet Transfusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood withdrawal | Diagnostic Test | — | UNRESOLVED |
| Questionnaire for former bleeding events | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- cohort
- description
- All patients fulfilling the eligibility criteria who can be asked for consent. Basic register of only patient diagnosis, treatment and bleeding yes or no (without identifiable information).
- label
- cases
- description
- Patient with clinically relevant bleeding, defined as major and clinically relevant non-major bleeding that leads to substantial additional medical care: WHO score 3-4 and part of the WHO score 2 bleedings (depending on the need for additional care).
- interventionNames
- Diagnostic Test: Blood withdrawal
- Other: Questionnaire for former bleeding events
- label
- controls
- description
- Patient without clinically relevant bleeding matched to a case patient based on diagnosis and therapy.
- interventionNames
- Diagnostic Test: Blood withdrawal
- Other: Questionnaire for former bleeding events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria are mentioned below and differ for part A and B of the study. * Admission in the hospital. (part A and B) * Age ≥ 18 years. (part A and B) AND: • Hemato-oncology patient, including MDS and AA, admitted for treatment (chemotherapy, SCT) who is (expected to become) thrombocytopenic with platelet counts of \< 50 for expected at least 5 days and who will possibly be treated with one or more prophylactic platelet transfusions. (part A and B) OR: • Hemato-oncology patient who had previous intensive chemotherapy or stem cell transplantation and who is admitted to the hematology ward for disease or treatment related events or complications. (part A only) Exclusion Criteria: • Patients with myeloproliferative disorders.
References
Publications (1)
- DERIVEDCornelissen LL, Caram-Deelder C, van der Bom JG, Middelburg RA, Zwaginga JJ. Risk factors for bleeding in haemato-oncology patients-a nested case-control study: The BITE study protocol (Bleeding In Thrombocytopenia Explained). BMJ Open. 2020 Jun 30;10(6):e034710. doi: 10.1136/bmjopen-2019-034710. PMID 32606056