Understanding bleeding risks in patients with blood cancers
Bleeding in Thrombocytopenia Explained
This study is trying to find out which blood cancer patients are more likely to bleed during chemotherapy so that doctors can better prevent and manage these risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT03505086 on ClinicalTrials.gov |
What this trial studies
This multicenter case cohort study investigates clinical risk factors and biomarkers associated with bleeding in hemato-oncology patients undergoing intensive chemotherapy. The study aims to identify patients at high and low risk for bleeding events, which could lead to more effective transfusion strategies and treatment approaches. Participants will complete a questionnaire about previous bleeding events and provide blood and urine samples for analysis. The goal is to improve the prediction and prevention of bleeding in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates include hemato-oncology patients aged 18 and older who are expected to become thrombocytopenic and may require prophylactic platelet transfusions.
Not a fit: Patients with myeloproliferative disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective treatments for preventing bleeding in hemato-oncology patients.
How similar studies have performed: While there have been studies on bleeding risks in similar populations, this specific approach to identifying risk factors and biomarkers is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Leiden, South Holland
- Lumc — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Loes Cornelissen, MD, PhD student
- Email: L.L.Cornelissen@lumc.nl
- Phone: +31 (0)71 5268872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.