Bleeding In Thrombocytopenia Explained

NCT03505086 | Recruiting

• 1 other identifier: PPOC 17-36
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hematologic Neoplasms; Bleeding; Hemorrhage; Platelet Transfusion

Outcome Measures

Primary Outcomes (1)

• Clinically relevant bleeding events

  Bleeding events that are clinically relevant. i.e. all WHO grade 3 and 4 bleedings, as well as WHO grade 2 bleedings that lead to substantial additional medical care (ISTH criteria). We will quantify the association of possible risk factors for bleeding with this primary outcome. These risk factors are listed in the protocol.

  Bleeding must occur during hospital admission, which on average will be 3-4 weeks.

Secondary Outcomes (2)

• Mortality

  During hospital admission, which on average will be 3-4 weeks.

• Duration of hospital stay

  At the day of discharge, which will be on average 3-4 weeks.

Study Arms (3)

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).

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).

Diagnostic Test: Blood withdrawal; Other: Questionnaire for former bleeding events

controls

Patient without clinically relevant bleeding matched to a case patient based on diagnosis and therapy.

Diagnostic Test: Blood withdrawal; Other: Questionnaire for former bleeding events

Interventions

Blood withdrawal DIAGNOSTIC_TEST

* 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.

Also known as: Collection of urine (with or without catheter)

cases; controls

Questionnaire for former bleeding events OTHER

Questionnaire to investigate a bleeding tendency before diagnosis.

cases; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hemato-oncology patients

You may qualify if:

• 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)

You may not qualify if:

• Patients with myeloproliferative disorders.

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead

Study Sites (1)

LUMC

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 32606056 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Citrate plasma and urine. NB: not all enrolled patients will be elligible for sampling, some enrolled patients are only elligible for epidemiological study.

MeSH Terms

Conditions

Hematologic Neoplasms; Hemorrhage

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Loes Cornelissen, MD, PhD student

CONTACT

+31 (0)71 5268872; L.L.Cornelissen@lumc.nl

Rutger Middelburg, PhD

CONTACT

+31 (0)71 5685060; R.A.Middelburg@lumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: April 23, 2018
• Study Start: December 4, 2018
• Primary Completion: October 1, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

NL (1)