Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bleeding In Thrombocytopenia Explained (BITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Hematologic Neoplasms Bleeding Hemorrhage Platelet Transfusion Diagnostic Test: Blood withdrawal Other: Questionnaire for former bleeding events

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Bleeding in Thrombocytopenia Explained
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
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
  • 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.

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Mortality [ Time Frame: During hospital admission, which on average will be 3-4 weeks. ]
    Mortality during hospital stay in bleeding vs non-bleeding patients

  2. 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


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Hemato-oncology patients
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505086


Contacts
Layout table for location 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

Locations
Layout table for location information
Netherlands
LUMC Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

Layout table for additonal information
Responsible Party: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
ClinicalTrials.gov Identifier: NCT03505086     History of Changes
Other Study ID Numbers: PPOC 17-36
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Thrombocytopenia
Hemorrhage
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Neoplasms by Site
Neoplasms