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Bleeding In Thrombocytopenia Explained (BITE)

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ClinicalTrials.gov Identifier: NCT03505086
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Tracking Information
First Submitted Date February 6, 2018
First Posted Date April 23, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date December 4, 2018
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
Clinically relevant bleeding events [ Time Frame: Bleeding must occur during hospital admission, which on average will be 3-4 weeks. ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03505086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
  • Mortality [ Time Frame: During hospital admission, which on average will be 3-4 weeks. ]
    Mortality during hospital stay in bleeding vs non-bleeding patients
  • Duration of hospital stay [ Time Frame: At the day of discharge, which will be on average 3-4 weeks. ]
    Duration of hospital stay in bleeding vs non-bleeding patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bleeding In Thrombocytopenia Explained
Official Title Bleeding in Thrombocytopenia Explained
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.
Detailed Description

Rationale: Hemato-oncological patients treated with intensive chemotherapy receive prophylactic platelet transfusions to prevent bleeding events as soon as their platelet counts drop below 10 x109/L. This platelet count based prophylactic transfusion strategy, however, is both inefficient and often not needed. This is reflected in the high percentage of patients with bleeding despite this strategy (43%), and the high percentage of patients who do not bleed without this strategy (50%). Solely platelet count therefore is not a good predictor for bleeding. Identification of new risk factors and confirmation of already suspected risk factors is essential, and should lead to better prediction and prevention of bleeding. Patients with a high risk profile could be given more effective haemostatic treatments including more efficient transfusion strategies. On the other hand one could consider omitting prophylactic transfusions to low risk patients and conditions. Furthermore, additional knowledge about the pathophysiology of bleeding in hemato-oncology patients is needed.

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Citrate plasma and urine. NB: not all enrolled patients will be elligible for sampling, some enrolled patients are only elligible for epidemiological study.
Sampling Method Probability Sample
Study Population Hemato-oncology patients
Condition
  • Hematologic Neoplasms
  • Bleeding
  • Hemorrhage
  • Platelet Transfusion
Intervention
  • Diagnostic Test: 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.
    Other Name: Collection of urine (with or without catheter)
  • Other: Questionnaire for former bleeding events
    Questionnaire to investigate a bleeding tendency before diagnosis.
Study Groups/Cohorts
  • 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).
    Interventions:
    • 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.
    Interventions:
    • Diagnostic Test: Blood withdrawal
    • Other: Questionnaire for former bleeding events
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 12, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2023
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Loes Cornelissen, MD, PhD student +31 (0)71 5268872 L.L.Cornelissen@lumc.nl
Contact: Rutger Middelburg, PhD +31 (0)71 5685060 R.A.Middelburg@lumc.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03505086
Other Study ID Numbers PPOC 17-36
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Study Sponsor Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Collaborators Not Provided
Investigators Not Provided
PRS Account Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Verification Date April 2019