This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device. Three hundred and twenty four subjects across a maximum of 25 investigational sites undergoing open elective cardiac, general, or urological surgical procedures who meet the eligibility criteria will be intraoperatively randomized to receive no more than the entire contents of up to two 5 gram bellows of either the investigational device or a control hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm² and whose anatomic application site is smaller than or equal to 47cm², when bleeding is within the pre-defined bleeding severity range after any applicable conventional means for hemostasis are attempted as specified in the intraoperative procedures. Each investigational site is expected to enroll approximately 13-40 subjects. All investigational sites will be located in the U.S. Follow-up will occur at hospital discharge and 6 weeks post-device application. For oncologic subjects, an additional follow up will occur at 24 months post device application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
324
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of PerClot. The prescribed hemostatic agent will be applied according to its Instructions for Use.
During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of the control device. The prescribed hemostatic agent will be applied according to its Instructions for Use.
Indiana University d/b/a/ Methodist Research Institute
Indianapolis, Indiana, United States
Number of Participants With Achievement of Hemostasis at 7 Minutes
The primary objective of this clinical investigation is to demonstrate non-inferiority in the achievement of hemostasis of the treated bleeding site at 7 minutes in participants receiving PerClot compared to those receiving a control hemostatic device. The primary endpoint is the percentage of participants achieving hemostasis of the treated lesion at 7 minutes in each treatment group.
Time frame: 7 minutes following application
Number of Participants With Achievement of Hemostasis at 5 Minutes
The secondary objective of this investigation is to compare the achievement of hemostasis of the treated bleeding site at 5 minutes for participants receiving PerClot compared to those receiving a control hemostatic device. The secondary endpoint is the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in each treatment group.
Time frame: 5 minutes following application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.