NCT03288441: MATTER

Management and Outcomes of Anti-thrombotic Medication Use in Thrombocytopenia

Status unknown Last updated 17 September 2020

What this trial tests

trial testing Hold in Hematologic Neoplasms in 300 participants. Status unknown.

Timeline

20 March 2018

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Maastricht University Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	20 March 2018
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	21 locations across Italy, Netherlands, United States, Israel

Drugs / interventions tested

• Hold
• Prophylactic dose antithrombotic — full drug profile →
• Change antithrombotic Drug — full drug profile →
• Change platelet transfusion threshold — full drug profile →
• Full dose antithrombotics — full drug profile →
• Mechanical measures
• Intermediate dose antithrombotic — full drug profile →

Conditions studied

• Hematologic Neoplasms — all drugs for Hematologic Neoplasms →
• Thrombocytopenia — all drugs for Thrombocytopenia →
• Anticoagulants — all drugs for Anticoagulants →
• Platelet Aggregation Inhibitors — all drugs for Platelet Aggregation Inhibitors →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Hematologic Neoplasms or Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.