Blood Loss, SurgicalCLOTNCT02359994
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
A study testing PerClot Polysaccharide Hemostatic System and Arista AH in people with Blood Loss, Surgical, run by Artivion Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- PerClot Polysaccharide Hemostatic System and Arista AH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)].
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University d/b/a/ Methodist Research Institute
Indianapolis, Indiana
About this study
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.
- Conditions
- Blood Loss, Surgical
- Being tested
- PerClot Polysaccharide Hemostatic System, Arista AH
- Keywords
- hemostasis
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerClot Polysaccharide Hemostatic SystemDevice
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.
Arista AHDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery | Experimental | 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. Receives: Device: PerClot Polysaccharide Hemostatic System; Device: Arista AH |
| General Surgery | Experimental | 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. Receives: Device: PerClot Polysaccharide Hemostatic System; Device: Arista AH |
| Urologic Surgery | Experimental | 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. Receives: Device: PerClot Polysaccharide Hemostatic System; Device: Arista AH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 minutes following application
Secondary outcomes (1)
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.
Measured: 5 minutes following application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startApr 2015
- Primary completion11 Jan 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artivion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael House, MD, Principal investigator, Indiana UniversityMarc Moon, MD, Principal investigator, Washington University School of MedicineWilliam Chapman, MD, Principal investigator, Washington University School of MedicineRonald P Kaufman, MD, Principal investigator, Albany Medical CollegeEdward Chen, MD, Principal investigator, Emory UniversityRobin Kim, MD, Principal investigator, University of UtahDerek DuBay, MD, Principal investigator, Medical University of South CarolinaAdam Yopp, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359994
- Sponsor's protocol ID
- PCT1101.011-C(02/15)
- Acronym
- CLOT
- Status last verified
- Mar 2022
- First submitted
- 3 Feb 2015
- Last updated
- 17 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
House MG, Kim R, Tseng EE, Kaufman RP Jr, Moon MR, Yopp A, Master VA. Evaluating the safety and efficacy of a novel polysaccharide hemostatic system during surgery: A multicenter multispecialty prospective randomized controlled trial. Surg Open Sci. 2024 May 3;19:205-211. doi: 10.1016/j.sopen.2024.04.009. eCollection 2024 Jun.
PubMed 38800121
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
- ClinicalTrials.gov ID
- NCT02359994
- Acronym / sponsor ID
- CLOT / PCT1101.011-C(02/15)
- Conditions
- Blood Loss, Surgical
- Keywords
- hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Artivion Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 17 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery | Experimental | Device: PerClot Polysaccharide Hemostatic System, Device: Arista AHFor 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. |
| General Surgery | Experimental | Device: PerClot Polysaccharide Hemostatic System, Device: Arista AHFor 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. |
| Urologic Surgery | Experimental | Device: PerClot Polysaccharide Hemostatic System, Device: Arista AHFor 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Preoperative inclusion:
- Intraoperative inclusion:
Key exclusion criteria (12 listed)
- Preoperative Exclusion Criteria
- Intraoperative Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerClot Polysaccharide Hemostatic SystemDuring 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. | Device | Cardiac Surgery, General Surgery, Urologic Surgery |
| Arista AHDuring 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. | Device | Cardiac Surgery, General Surgery, Urologic Surgery |
Primary outcome
Number of Participants With Achievement of Hemostasis at 7 Minutes
Time frame: 7 minutes following application
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.
1 secondary outcome
Number of Participants With Achievement of Hemostasis at 5 Minutes
Time frame: 5 minutes following application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38800121House MG, Kim R, Tseng EE, Kaufman RP Jr, Moon MR, Yopp A, Master VA. Evaluating the safety and efficacy of a novel polysaccharide hemostatic system during surgery: A multicenter multispecialty prospective randomized controlled trial. Surg Open Sci. 2024 May 3;19:205-211. doi: 10.1016/j.sopen.2024.04.009. eCollection 2024 Jun.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael House, MD principal investigator
Indiana University
Marc Moon, MD principal investigator
Washington University School of Medicine
William Chapman, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerClot Polysaccharide Hemostatic System and Arista AH in people with Blood Loss, Surgical, run by Artivion Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Achievement of Hemostasis at 7 Minutes (time frame: 7 minutes following application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.