Topical r-Hirudin ( Thrombexx ) Efficacy in Treatment of Haematomas

Summary

Single centre ,Phase IV , interventional, The study includes : 200 patients, 100 Patients will have Topical r-Hirudin (Thrombexx) and 100 patients will have placebo . The patients will be randomized to the active product (arm 1) or to placebo (arm 2). The study consists of 4 visits as the following : * Visit 1 : on day 1 to check patient eligibility and also for randomization . * Visit 2 : on day 4 to assess target parameters * Visit 3 : on day 8 to assess target parameters * Visit 4 : on day 16 to assess target parameters

Timeline

Start

2013-10

Primary completion

2014-01

Completion

2014-04

Publications

• El-Mowafi H, El Araby A, Kandil Y, Zaghloul A. Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas. Res Pract Thromb Haemost. 2017 Nov 6;2(1):139-146. doi: 10.1002/rth2.12049. eCollection 2018 Jan.

Drugs

Indications