Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00721760
Brief Summary:
The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing hip fracture surgery.
The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.
Detailed Description:
Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).
The total duration of observation per participant was 35-42 days from surgery broken down as follows:
* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.
Mandatory bilateral venography of the lower limbs had to be performed between 7 to 11 days after surgery.
Study:
NCT00721760
Study Brief:
Protocol Section:
NCT00721760