Back to resultsProspective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System (CLOT)
Primary Purpose
Blood Loss, Surgical
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PerClot Polysaccharide Hemostatic System
Arista AH
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss, Surgical focused on measuring hemostasis
Eligibility Criteria
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.
Sites / Locations
- Indiana University d/b/a/ Methodist Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cardiac Surgery
General Surgery
Urologic Surgery
Arm Description
For cardiac procedures, the site of evaluation for satisfaction of intraoperative eligibility criteria will be any bleeding sites on the epicardium, along an aortic anastomotic suture line, or an aortotomy suture line. For example, the surgeon will perform dissection of adhesions per his or her conventional methods and bleeding will be controlled using means continually employed by the surgeon prior to surgical closure. Prior to application along an aortic anastomotic suture line or an aortotomy suture line, suture line gaps > 2mm and large needle holes > 2mm will be ligated prior to assessment of intraoperative eligibility criteria. Any bleeding site on the epicardium, or along an aortic anastomotic suture line, or an aortotomy suture line meeting the eligibility criteria will be evaluated for satisfaction. PerClot should be applied after drug reversal and the patient is taken off by-pass.
For liver resection procedures, the resected liver surface will be the site of evaluation. The surgeon will perform resection of the diseased portion of the liver per his/her conventional methods. Bleeding from discrete vessels will be controlled using means conventionally employed by the surgeon. Vessels > 2mm in diameter will be ligated and any observed bile leaks controlled prior to assessment of intraoperative eligibility criteria. For total splenectomy procedures, the site of evaluation for satisfaction of the intraoperative eligibility criteria will be the retroperitoneal surface. The surgeon will perform the splenectomy per his/her conventional methods. Vessels > 2mm in diameter will be ligated prior to assessment of intraoperative eligibility criteria. Any bleeding site on the retroperitoneal surface/cavity or exposed parenchymal surface will be evaluated for satisfaction of the eligibility criteria.
For on-clamp partial nephrectomies, the site of evaluation will be the kidney bed surface. The surgeon will perform resection of the kidney per his or her conventional methods. Vessels > 2mm in diameter will be ligated and entries into the collecting system controlled prior to assessment of intraoperative eligibility criteria. Any bleeding site on the kidney bed will be evaluated for satisfaction of the eligibility criteria after clamp release. For radical nephrectomies, the site of evaluation will be the retroperitoneal surface/cavity. The surgeon will perform the procedure per his or her conventional methods. Vessels > 2mm in diameter will be ligated prior to assessment of intraoperative eligibility criteria. Any bleeding site on the retroperitoneal surface/cavity will be evaluated for satisfaction of the eligibility criteria.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02359994
Brief Title
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
Acronym
CLOT
Official Title
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Artivion Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Surgery
Arm Type
Experimental
Arm Description
For cardiac procedures, the site of evaluation for satisfaction of intraoperative eligibility criteria will be any bleeding sites on the epicardium, along an aortic anastomotic suture line, or an aortotomy suture line. For example, the surgeon will perform dissection of adhesions per his or her conventional methods and bleeding will be controlled using means continually employed by the surgeon prior to surgical closure. Prior to application along an aortic anastomotic suture line or an aortotomy suture line, suture line gaps > 2mm and large needle holes > 2mm will be ligated prior to assessment of intraoperative eligibility criteria. Any bleeding site on the epicardium, or along an aortic anastomotic suture line, or an aortotomy suture line meeting the eligibility criteria will be evaluated for satisfaction. PerClot should be applied after drug reversal and the patient is taken off by-pass.
Arm Title
General Surgery
Arm Type
Experimental
Arm Description
For liver resection procedures, the resected liver surface will be the site of evaluation. The surgeon will perform resection of the diseased portion of the liver per his/her conventional methods. Bleeding from discrete vessels will be controlled using means conventionally employed by the surgeon. Vessels > 2mm in diameter will be ligated and any observed bile leaks controlled prior to assessment of intraoperative eligibility criteria.
For total splenectomy procedures, the site of evaluation for satisfaction of the intraoperative eligibility criteria will be the retroperitoneal surface. The surgeon will perform the splenectomy per his/her conventional methods. Vessels > 2mm in diameter will be ligated prior to assessment of intraoperative eligibility criteria.
Any bleeding site on the retroperitoneal surface/cavity or exposed parenchymal surface will be evaluated for satisfaction of the eligibility criteria.
Arm Title
Urologic Surgery
Arm Type
Experimental
Arm Description
For on-clamp partial nephrectomies, the site of evaluation will be the kidney bed surface. The surgeon will perform resection of the kidney per his or her conventional methods. Vessels > 2mm in diameter will be ligated and entries into the collecting system controlled prior to assessment of intraoperative eligibility criteria. Any bleeding site on the kidney bed will be evaluated for satisfaction of the eligibility criteria after clamp release.
For radical nephrectomies, the site of evaluation will be the retroperitoneal surface/cavity. The surgeon will perform the procedure per his or her conventional methods. Vessels > 2mm in diameter will be ligated prior to assessment of intraoperative eligibility criteria. Any bleeding site on the retroperitoneal surface/cavity will be evaluated for satisfaction of the eligibility criteria.
Intervention Type
Device
Intervention Name(s)
PerClot Polysaccharide Hemostatic System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Arista AH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Achievement of Hemostasis at 7 Minutes
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Achievement of Hemostasis at 5 Minutes
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael House, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Moon, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Chapman, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald P Kaufman, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Chen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Kim, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek DuBay, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Yopp, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Argenziano, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K. Scott Coffield, MD
Organizational Affiliation
Baylor Scott and White Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Castellucci, DO
Organizational Affiliation
Manatee Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Viraj Master, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kiran Turaga, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlo B Ramirez, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith B Allen, MD
Organizational Affiliation
St. Luke's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elaine Tseng, MD
Organizational Affiliation
San Francisco VA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Jessen, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael D'Angelica, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Silberstein, MD, MPH
Organizational Affiliation
Tulane University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S.Chris Malaisrie, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles St. Hill, MD
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas Scherr, MD
Organizational Affiliation
Weill Cornell Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Guzzo, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron Milbank, MD
Organizational Affiliation
Minnesota Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University d/b/a/ Methodist Research Institute
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
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