Lotus has a vast amount of experience in performing trials on topical hemostats and has been integrally involved with the following programs: 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, have developed proprietary TTH models and offer an investigator training course in order to standardize TTH measurements between study centers.
Time to Hemostasis Measurements:
Although at first TTH measurements appear to be straightforward, they actually require a significant amount of experience to standardize and accurately capture. At Lotus, 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 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:
- Rapid and reliable recruitment (an average of 16 patients per month)
- 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
Video Education Courses:
The hemostasis endpoint has a subjective component which can give rise to variability and therefore negatively impact the ability of the investigation to achieve statistical significance. In order to standardize the method in which the TTH measurement is captured at all participating centers, Lotus offers an investigator training course.
|Phase||Indication||Sponsor||Pts per month Lotus*||Pts per month Non-Lotus*||Comments||ClinicalTrials.gov Identifier|
|2||Vascular||Zymogenetics||7||1||Top Enroller||Predates CTG|
|1/2||Spinal||Zymogenetics||12||2||Top Enroller||Predates CTG|
|3||Spinal/ Vascular||Zymogenetics||10.2||1.8||Top Enroller||NCT00245336|
|3b||Spinal/ Vascular||Zymogenetics||7||0.6||Top Enroller||NCT00491608|
|4||Liver Surgery||Zymogenetics||4.5||N/A||Single Center, IIT||Not Registered|
|2||Spinal/ Vascular/ Soft Tissue||ProFibrix||4.2||0.5||Top Enroller||NCT01256164|
|3||Vascular/Soft Tissue||ProFibrix||24||1.5||Top Enroller||NCT01527357|
*Each clinical trial has its own enrollment challenges therefore, the only way to judge a site’s enrollment is to compare it to other research sites that performed the same study concurrently. Therefore, Lotus tabulates its enrollment performance at the end of each study in the following way: (1) the number of patients enrolled by Lotus is divided by the number of months of active enrollment to generate a patient-per-month figure. (2) the number of patients enrolled by all other centers over the open enrollment period is calculated (x). That number (x) is then divided by the number of months of open enrollment and then again by the number of non-Lotus sites to generate an average non-Lotus site patient-per-month figure. In this way an “apples to apples” comparison can be made; and isn’t that what we are all striving for?