Conditions: Deep Vein Thrombosis
Keywords: Acute, symptomatic and objectively confirmed DVT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 541
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: innohep® 175 anti-Xa IU/kg once daily arm 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Interventions: intervention 1: innohep® intervention 2: Heparin
Intervention descriptions: intervention 1: 175 anti-Xa IU/kg administered subcutaneously (SC) once daily intervention 2: Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.

Protocol document: