Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2018-12-04
2026-06-01
Brief Summary
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Detailed Description
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Objective: Identify hemato-oncology patients and conditions with a high versus a low bleeding risk and investigate the association of bleeding related biomarkers with bleeding.
Study design: Case cohort study, consisting of two parts: epidemiologically research including short questionnaire (part A, eligible for all patients fulfilling inclusion criteria), and additional blood and urine sampling (part B, eligible only for included patients admitted for chemotherapy or stem cell transplantation).
Study population: Adult hemato-oncology patients: 1.) who are admitted for treatment and who have or will develop thrombocytopenia and are likely to receive one or more prophylactic platelet transfusions, and 2.) patients who have received such treatments in the last year but are readmitted to the hospital for disease or treatment related adverse events.
Intervention: Part A: standard available data collection, short questionnaire. Part B: sampling of blood and urine on top of routinely performed laboratory tests.
Main study parameters: Part A: The presence of clinical factors and results of routinely performed laboratory tests compared between bleeding versus non-bleeding patients. Part B: Presence of markers for coagulation-, platelet- and endothelial or vascular dysfunction compared between bleeding versus non-bleeding patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Part A: No burden or health risks: comparison of standard available data between bleeding and non-bleeding patients makes this a non-WMO part of the study, since there is no invasive intervention. The 10-15 minutes questionnaire in this respect is not considered as a burden. Part B of the study only applies for a subgroup of the included patients and falls under the scope of the WMO. The intervention is the additional to regularly performed citrate anticoagulated blood sampling (maximum 10 samples of 10-15 cc in 4 weeks), as well as weekly urine sampling. Both are considered a minor burden for participants, and the risk of additional blood sampling at regular sampling moments is negligible. Finally, all BITE-study activities in both study parts will not have any consequences on the treatment or monitoring of patients.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cohort
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).
No interventions assigned to this group
cases
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).
Blood withdrawal
* Blood withdrawal will be at regular sampling moments, blood can be collected from a central venous catheter or venepuncture procedure.
* Blood withdrawal will be performed for a maximum of 10 times per admission, 10 ml per time.
* Urine sampling will be for a maximum of 5 times per admission.
* Urine can be sampled from a catheter when present, or collected regular.
Questionnaire for former bleeding events
Questionnaire to investigate a bleeding tendency before diagnosis.
controls
Patient without clinically relevant bleeding matched to a case patient based on diagnosis and therapy.
Blood withdrawal
* Blood withdrawal will be at regular sampling moments, blood can be collected from a central venous catheter or venepuncture procedure.
* Blood withdrawal will be performed for a maximum of 10 times per admission, 10 ml per time.
* Urine sampling will be for a maximum of 5 times per admission.
* Urine can be sampled from a catheter when present, or collected regular.
Questionnaire for former bleeding events
Questionnaire to investigate a bleeding tendency before diagnosis.
Interventions
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Blood withdrawal
* Blood withdrawal will be at regular sampling moments, blood can be collected from a central venous catheter or venepuncture procedure.
* Blood withdrawal will be performed for a maximum of 10 times per admission, 10 ml per time.
* Urine sampling will be for a maximum of 5 times per admission.
* Urine can be sampled from a catheter when present, or collected regular.
Questionnaire for former bleeding events
Questionnaire to investigate a bleeding tendency before diagnosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
OTHER
Responsible Party
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Locations
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LUMC
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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References
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Cornelissen 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.
Other Identifiers
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PPOC 17-36
Identifier Type: -
Identifier Source: org_study_id