Lotus Clinical Research has a vast amount of experience in performing trials on topical hemostats and has been integrally involved with the following programs: Grifols (topical human thrombin), Zymogenetics (recombinant human thrombin), King Pharmaceuticals (bovine thrombin), and Profibrix (fibrocaps spray thrombin).
We are well published in the field of topical hemostats and have been the highest enrolling site in nearly every one of our hemostatic investigations. We are facile at performing TTH measurements and have developed proprietary TTH measurements between study centers.
While TTH measurements may appear to be straightforward at first, they actually require a significant amount of experience to standardize and accurately capture. At Lotus Clinical Research, we have performed over 500 TTH measurements in various hemostatic models including:
Through this experience, we have learned several nuances that help us select appropriate bleeding sites, follow detailed TTH protocols, and accurately determine when hemostasis has been achieved. Additionally, we are skilled at identifying rebleeds per the strict definition of the study protocol.
Lotus Clinical Research has developed two proprietary surgical hemostatic models, mastopexy and abdominoplasty, that can be integrated into early or late phase clinical trials on surgical bleeding. These models have several advantages over classic bleeding models such as spine surgery and vascular surgery, including: