Home∕Analgesic Expertise∕Hemostasis Hemostasis 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. Time to Hemostasis Measurements 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: Spine surgery (epidural bleeding) Vascular surgery (anastomotic bleeding) Soft tissue surgery (diffuse venous ooze) Laparoscopic surgery (parenchymal bleeding) 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. Proprietary High Volume Low Variability Hemostasis Models 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: Variability reduction due to: (1) multiple potential bleeding areas to be utilized as hemostatic targets so that the surgeon can pick uniform sites among the full cohort of subjects, reducing inter-subject variability; (2) single surgeon performing all operations therefore improving intra-rater reliability. Low intraoperative screen fail rate (=5%). Standard of care does not involve anticoagulation for these subjects. Patients involved in these models are generally healthy with few adverse events which leads to less confounding of the investigational product’s true adverse event profile. High-volume recruitment per site improves timelines and provides significant cost efficiencies secondary to decreased monitoring and start up expenditures. August 21, 2017 Abdominoplasty Bleeding Model August 21, 2017 Mastopexy Bleeding Model CRO SERVICES SITE SERVICES PLACEBO RESPONSE MITIGATION ANALGESIC EXPERTISE RESOURCE WHO WE ARE Participate in Trial Contact Us Terms of Use Privacy Policy © 2021 Lotus Clinical Research, LLC. All Rights Reserved.