Management and Outcomes of Anti-thrombotic Medication Use in Thrombocytopenia
NCT ID: NCT03288441
Last Updated: 2020-09-17
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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UNKNOWN
300 participants
OBSERVATIONAL
2018-03-20
2021-12-31
Brief Summary
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Aims: The study aims are to evaluate how physicians manage anticoagulant and antiplatelet medication in patients with hematological malignancy and thrombocytopenia, and to assess the frequency of bleeding and thrombosis. Additional aims are to assess how management changes affect drug activity and blood clotting (coagulation), and to evaluate the use of platelet transfusions.
Design: The investigators plan a multinational prospective registry of patients admitted to the inpatient hematology department or outpatient clinic at one of the study centers. Patients with hematological malignancies, platelets below 50 X 109/L, and anticoagulant and/or antiplatelet medication will be studied.
Patients will be enrolled when the combination of antiplatelet/anticoagulant medication and thrombocytopenia is first detected. Patients will be followed until 30 days after the baseline study visit (which occurs 30 days after enrollment or when platelets \< 50\*109/L, whichever come first) or death. Patients will be indexed at the time of baseline visit.
Patients will be excluded from study analysis if one of the following events occurs before study index: Withdrawal of consent, death, clinically-relevant non-major bleeding or the composite primary outcome.
Risk factors for bleeding and thrombosis will be recorded at baseline. Parameters from routine blood tests will be recorded throughout the study. During the study major bleeding events and thrombosis will be recorded. Investigational blood tests assessing coagulation and drug activity will be drawn at baseline (=study index). Throughout the study all management decisions regarding antithrombotic therapy, including platelet and red blood cell transfusion, will be recorded. This is an observational study and management will be solely at the discretion of the physician.
Analysis: The investigators will first look at the frequency of either bleeding or thrombosis according to the type of management strategy and evaluate the platelet threshold at which a given management strategy is employed.
At the next stage, in selected subgroups, the optimal management strategy with respect to bleeding/thrombotic risk, will be determined.
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Detailed Description
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1. Thrombocytopenic Cohort: Patients with morning platelet count below 50\*109/L at study index. This is the main study cohort for all analyses
2. Non-thrombocytopenic Cohort: Patients whose morning platelet count is ≥ 50\*109/L at study index will be considered as a reference group, and not included in the primary analysis.
* Analysis of outcomes:
By definition, there will be an intervention at the time of study index (baseline), meaning that even if no change is made, it will be considered an intervention. Each patient may have multiple exposures/interventions over the study.
Therefore, in a time dependent analysis, each outcome will be linked to the exposure/intervention at study index.
Each exposure/intervention will be linked with the platelet level on the day of the intervention.
#Competing Events:
The following events (in addition to death) will be considered competing events and will be considered as such in the statistical analyses of the outcomes:
1. The composite primary outcome
2. change in the antithrombotic regimen after study index
3. diagnosis of HIT or TTP
4. a change in the hematological malignancy treatment regimen. Study follow-up will continue after these events, and study data will continue to be recorded until censorship for end of study period or death.
* Detecting selection bias:
Patients fulfilling the inclusion criteria but not included in the study, will be detected by reviewing the medical records of the hematology institute, weekly. The baseline characteristics and reason for not including these patients will be recorded retrospectively in the "not-included cohort". The baseline characteristics of this cohort will be compared with the study cohort to ascertain whether selection bias exists.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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antiplatelet only
Patients receiving antiplatelet medication, but not anticoagulation. Antiplatelet drugs include any class, dose or duration of any platelet aggregation inhibitor.
This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped)
Hold
Hold antithrombotic therapy
Change antithrombotic Drug
Change in type of antithrombotic therapy
Change platelet transfusion threshold
Increase or reduce platelet transfusion threshold
Full dose antithrombotics
Continue full dose antithrombotic therapy
anticoagulant-based
Patients receiving only anticoagulants or both anticoagulant and antiplatelet medication combined. This includes any class, dose or duration of any antiplatelet or anticoagulant drug.
This refers to the antithrombotic regimen when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped)
Hold
Hold antithrombotic therapy
Prophylactic dose antithrombotic
Reduction in antithrombotic medication dose to prophylactic dose (without changing type)
Change antithrombotic Drug
Change in type of antithrombotic therapy
Change platelet transfusion threshold
Increase or reduce platelet transfusion threshold
Full dose antithrombotics
Continue full dose antithrombotic therapy
Mechanical measures
Mechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter
Intermediate dose antithrombotic
Reduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose
Interventions
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Hold
Hold antithrombotic therapy
Prophylactic dose antithrombotic
Reduction in antithrombotic medication dose to prophylactic dose (without changing type)
Change antithrombotic Drug
Change in type of antithrombotic therapy
Change platelet transfusion threshold
Increase or reduce platelet transfusion threshold
Full dose antithrombotics
Continue full dose antithrombotic therapy
Mechanical measures
Mechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter
Intermediate dose antithrombotic
Reduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose
Eligibility Criteria
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Inclusion Criteria
* Disease-related and/or current/predicted treatment-related thrombocytopenia (\<50 X 109/L) of any duration.
* Current antiplatelet and/or anticoagulant treatment of any duration and for any indication. This treatment may have been started before or after diagnosis of the hematological malignancy and thrombocytopenia.
"Current" refers to the time when the current thrombocytopenia, or risk thereof (i.e. "predicted"), was first identified (even if the treatment is subsequently stopped)
Exclusion Criteria
* Current diagnosis of heparin induced thrombocytopenia (HIT) or thrombotic thrombocytopenia purpura (TTP)
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Avi Leader, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center, Petah Tikva, Israel
Hugo ten Cate, MD, PhD
Role: STUDY_CHAIR
Maastricht University Medical Center, Maastricht
Anna Falanga, MD
Role: STUDY_CHAIR
A.O. Papa Giovanni XXIII - S.I.M.T.
Locations
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Oregon Health & Science University Hospital
Portland, Oregon, United States
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo di Alessandria
Alessandria, , Italy
A.O. Papa Giovanni XXIII - S.I.M.T.
Bergamo, , Italy
ASST degli Spedali Civili di Brescia
Brescia, , Italy
A.O.U. di Modena
Modena, , Italy
Ospedale San Gerardo di Monza
Monza, , Italy
University Hospital Policlinico di Palermo
Palermo, , Italy
A.O.U Policlinico Umberto I di Roma
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Università degli studi di Roma "Tor Vergata"
Roma, , Italy
A.O.U. CITTA' della SALUTE e della SCIENZA di TORINO
Torino, , Italy
AZIENDA ULSS N. 8 BERICA di Vicenza
Vicenza, , Italy
Amsterdam University Medical Centers
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Maastricht University Medical Center (MUMC+)
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Yona Nadir, MD, PhD
Role: primary
Sergio Siragusa, MD
Role: primary
Other Identifiers
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METC 17-4-061
Identifier Type: -
Identifier Source: org_study_id
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