Management and Outcomes of Anti-thrombotic Medication Use in Thrombocytopenia
MATTER
Management Patterns of AntiThrombotics and Outcomes in Patients With Hematological Malignancy and ThrombocytopEnia: a Prospective Registry (MATTER Study)
1 other identifier
observational
300
4 countries
21
Brief Summary
Background: Antithrombotic therapy in the context of treatment related thrombocytopenia (i.e. low levels of platelets) is not uncommon. Guidelines are based upon a paucity of retrospective data and focus on the scenario of cancer associated venous thrombosis and low molecular weight heparin treatment. Even less is known regarding direct oral anticoagulants, antiplatelet therapy, or anticoagulation prescribed for other indications. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedStudy Start
First participant enrolled
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 17, 2020
September 1, 2020
2.8 years
September 7, 2017
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of major bleeding or thrombosis
1\) ISTH-defined Major bleeding events defined as: Fatal bleeding; bleeding into a critical organ; clinically overt bleeding associated with a decrease in hemoglobin level of more than 2 g/dL or leading to the transfusion of two or more units of blood OR: 2) Thrombosis defined as: Any symptomatic deep or superficial venous or arterial thromboembolism demonstrated on objective imaging/laboratory tests. Ischemic strokes with no immediate imaging signs will also be considered events, provided this was diagnosed by a neurologist and that the patient had objective neurological signs.
30 days (from study index) or until death (whichever first)
Secondary Outcomes (6)
Platelet transfusion related adverse effects
30 days (from study index) or until death (whichever first)
Clinically Relevant non-Major Bleeding
30 days (from study index) or until death (whichever first)
Number of platelet tranfusions
30 days (from study index) or until death (whichever first)
Number of RBC tranfusions
30 days (from study index) or until death (whichever first)
Death
30 days (from study index)
- +1 more secondary outcomes
Other Outcomes (2)
peak anticoagulant intensity
3 days after study index
Whole blood coagulation
3 days after study index
Study Arms (2)
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)
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)
Interventions
Reduction in antithrombotic medication dose to prophylactic dose (without changing type)
Change in type of antithrombotic therapy
Increase or reduce platelet transfusion threshold
Continue full dose antithrombotic therapy
Mechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter
Reduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose
Eligibility Criteria
Subjects treated at the inpatient or outpatient hematology departments at the participating centers
You may qualify if:
- Any hematological malignancy with or without active treatment (including autologous or allogeneic stem cell transplantation), irrespective of the treatment line and disease status.
- 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)
You may not qualify if:
- Previous thrombocytopenia (\<50 X 109/L) while using the current antithrombotic regimen.
- Current diagnosis of heparin induced thrombocytopenia (HIT) or thrombotic thrombocytopenia purpura (TTP)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
Rambam Health Care Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo di Alessandria
Alessandria, 15121, Italy
A.O. Papa Giovanni XXIII - S.I.M.T.
Bergamo, 24127, Italy
ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
A.O.U. di Modena
Modena, 41125, Italy
Ospedale San Gerardo di Monza
Monza, Italy
University Hospital Policlinico di Palermo
Palermo, Italy
A.O.U Policlinico Umberto I di Roma
Roma, 00161, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168, 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, 36100, Italy
Amsterdam University Medical Centers
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Maastricht University Medical Center (MUMC+)
Maastricht, 6229 HX, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
HagaZiekenhuis
The Hague, 2545 AA, Netherlands
Biospecimen
After measuring the activity of anticoagulant drugs from the plasma when doses are modified, remaining plasma will be retained for 5 years.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avi Leader, MD
Rabin Medical Center, Petah Tikva, Israel
- STUDY CHAIR
Hugo ten Cate, MD, PhD
Maastricht University Medical Center, Maastricht
- STUDY CHAIR
Anna Falanga, MD
A.O. Papa Giovanni XXIII - S.I.M.T.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2017
First Posted
September 20, 2017
Study Start
March 20, 2018
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
September 17, 2020
Record last verified: 2020-09