The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
541
Bulgaria - managed by CRO
Sofia, Bulgaria
Croatia - managed by CRO
Zagreb, Croatia
Czech Republic - managed by CRO
Prague, Czechia
Hôpital de la Cavale Blanche
Brest, France
Number of Patients With Clinically Relevant Bleeding Events
Time frame: prior to day 90 +/- 5
Number of Patients With Recurrence of Venous Thromboembolism
Time frame: prior to day 90 +/- 5
Number of Patients With Major Bleeding Events
Time frame: prior to day 90 +/- 5
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Med. Klinik IV/Klinikum Darmstadt
Darmstadt, Germany
Klinika Chirugii Naczyniowej
Szczecin, Poland
Romania - managed by CRO
Bucharest, Romania
Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade
Belgrade, Serbia
Service of Geriatry, Hospital Universitario Clínico San Carlos
Madrid, Spain