Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System

Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System

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.

Inclusion Criteria:

• Preoperative inclusion:

  • Subject is undergoing one of the following open elective cardiac, general, or urological surgical procedures: Cardiac procedure (Epicardium); Cardiac procedure (aortic anastomosis or aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
  • Subject is willing and able to give prior written informed consent for investigation participation; and
  • Subject is > 22 years of age.

• Intraoperative inclusion:

  • Subject is undergoing one of the following elective procedures: Cardiac procedure (Epicardium); Cardiac procedure (Aortic Anastomosis or Aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
  • Subject in whom all visible vessels or suture holes greater than or equal to 2mm in diameter have been ligated;
  • Subject in whom there is bleeding at the specified area for each surgical procedure after any applicable conventional means for hemostasis are attempted as specified by the intraoperative protocol;
  • Subject in whom the anatomic site is equal to or less than 25cm²;
  • Subject in whom the anatomic application site is equal to or less than 47cm²; and
  • Subject in whom the bleeding flux from the identified lesion is > 0.000040[g/(cm²•s)] and ≤0.013[g/(cm²•s)].

Exclusion Criteria:

• Preoperative Exclusion Criteria

  • Subject with known sensitivity to starch or starch-derived materials;
  • Subject who has a clinically significant coagulation disorder or disease, defined as a platelet count <100,000 per microliter, International Normalized Ratio >1.5, or a PTT more than 1.5 times outside the laboratory's normal reference range;
  • Subject who used corticosteroids (excluding inhalers, eye-drops, and dermatologic corticosteroids) within 6 weeks prior to surgery;
  • Subject who has been treated with an investigational product and has not completed the entire follow-up period for that investigational product;
  • Subject who is pregnant (as confirmed by pregnancy test), planning on becoming pregnant during the follow-up period, or actively breast-feeding; and
  • Subject with poor blood glucose control as per glycosylated hemoglobin > 9%.

• Intraoperative Exclusion Criteria

  • Subject undergoing a cardiac procedure in which there is no aortic anastomosis or aortotomy suture line to evaluate using the bleeding severity scale (i.e., not for treatment at the distal coronary artery bypass graft anastomosis);
  • Subject in whom any major intraoperative bleeding incidences during the surgical procedure occurred (i.e., subject with assignment of an American College of Surgeons Advanced Trauma Life Support Hemorrhage Class of II, III, or IV Hemorrhage);
  • Subject who has an active or potential infection at the surgical site, or whose surgical wound is defined as a wound classification of CO (Contaminated) or D (Dirty or Infected) based upon the Center for Disease Control and Prevention's wound classification system; and
  • Subject who has undergone platelet receptor GP IIb/IIIa antagonist therapy less than 48 hours prior to surgery.