Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures
NCT ID: NCT02954029
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
315 participants
INTERVENTIONAL
2016-04-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Use of hemostasis pad that accelerates blood clotting has become an effective alternative. The ezClot pad is a new product that uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin. The positively charged chitosan molecules attract the negatively charged blood cells and platelets, thus promoting clots. The ability to hemostasis of chitosan has been proven with the HemCon® pad (HemCon Medical Technologies, Inc., Portland, OR, USA). This study was designed to confirm the safety and efficacy of the ezClot pad in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Transradial approach is increasing used during coronary procedures. The most important benefit of transradial approach compared to transfemoral approach is low risk of major bleeding. Widely used method for hemostasis of radial puncture sites were manual or device-assisted compression. There is yet only a limited data regarding the use of hemostasis pad after transradial approach. The hypothesis will be tested in the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent transradial coronary procedures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study group (transradial cohort)
device-assisted compression with ezClot pad
ezClot (hemostasis pad)
ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.
Rotary compression device
Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.
Study group (transfemoral cohort)
manual compression with ezClot pad
ezClot (hemostasis pad)
ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.
Control group (transradial cohort)
Rotary compression device
Rotary compression device
Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.
Control group (transfemoral cohort)
manual compression with BloodSTOP ix pad
BloodSTOP ix pad
BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ezClot (hemostasis pad)
ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.
BloodSTOP ix pad
BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Rotary compression device
Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients undergoing invasive procedures via the radial or femoral arteries
Exclusion Criteria
* platelet count \<50,000/ μL
* hypersensitivity to shrimps, lobsters or beetles
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Bundang Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Si-Hyuck Kang
professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
In-Ho Chae
Role: primary
Si-Hyuck Kang
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, Guagliumi G, Kornowski R, Wohrle J, Dudek D, Weisz G, Stone GW. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011 Oct 18;58(17):1750-6. doi: 10.1016/j.jacc.2011.07.021.
Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation. 2006 Aug 22;114(8):774-82. doi: 10.1161/CIRCULATIONAHA.106.612812. Epub 2006 Aug 14.
Pusateri AE, Holcomb JB, Kheirabadi BS, Alam HB, Wade CE, Ryan KL. Making sense of the preclinical literature on advanced hemostatic products. J Trauma. 2006 Mar;60(3):674-82. doi: 10.1097/01.ta.0000196672.47783.fd.
Arbel J, Rozenbaum E, Reges O, Neuman Y, Levi A, Erel J, Haskia AR, Caneti M, Sherf M, Mosseri M. USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study. EuroIntervention. 2011 Apr;6(9):1104-9. doi: 10.4244/EIJV6I9A192.
Ferretti L, Qiu X, Villalta J, Lin G. Efficacy of BloodSTOP iX, surgicel, and gelfoam in rat models of active bleeding from partial nephrectomy and aortic needle injury. Urology. 2012 Nov;80(5):1161.e1-6. doi: 10.1016/j.urology.2012.06.048. Epub 2012 Aug 22.
Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL. A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):660-7. doi: 10.1002/ccd.22615.
Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268.
Dai N, Xu DC, Hou L, Peng WH, Wei YD, Xu YW. A comparison of 2 devices for radial artery hemostasis after transradial coronary intervention. J Cardiovasc Nurs. 2015 May-Jun;30(3):192-6. doi: 10.1097/JCN.0000000000000115.
Choi EY, Ko YG, Kim JB, Rhee J, Park S, Choi D, Jang Y, Shim WH, Cho SY. Hemostatic efficacy of hydrophilic wound dressing after transradial catheterization. J Invasive Cardiol. 2005 Sep;17(9):459-62.
Kang SH, Han D, Kim S, Yoon CH, Park JJ, Suh JW, Cho YS, Youn TJ, Chae IH. Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial. PLoS One. 2017 Jul 24;12(7):e0181099. doi: 10.1371/journal.pone.0181099. eCollection 2017.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ezClot1
Identifier Type: -
Identifier Source: org_study_id