Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

Coronary Artery Disease Clinical Trial

Official title:

Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02954029
• Other study ID #: ezClot1
• Status: Recruiting
• Phase: Phase 4
• First received: July 12, 2016
• Last updated: November 2, 2016
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Seoul National University Bundang Hospital
• Contact: In-Ho Chae
• Email: ihchae[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Arterial access is the key step during the endovascular treatment of cardiovascular diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad using chitosan 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. The hypothesis will be tested among 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 tranradial coronary procedures.

Description:

Arterial access is the key step during the endovascular treatment of cardiovascular diseases. However, failure in hemostasis of the arterial access sites is associated with high risk of complications such as bleeding, pseudoaneurysm, and arteriovenous fistula. Major bleeding events after percutaneous coronary intervention has been shown be associated with poor short-term as well as long-term prognosis. Thus, there have been a variety of approaches to quickly and effectively achieve hemostasis of the puncture site. The traditional method was to apply manual compression followed by simple dressing directly on the puncture site. Despite a long history and economic advantage, this method required prolonged hemostasis time, substantial efforts by trained practitioner, and patients' discomfort.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 years or older

• patients undergoing invasive procedures via the radial or femoral arteries

Exclusion Criteria:

• congenital or acquired bleeding tendency

• platelet count <50,000/ µL

• hypersensitivity to shrimps, lobsters or beetles

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Puncture

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, Guagliumi G, Kornowski R, Wöhrle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hb at discharge	hemoglobin (g/dL) within 24 hours	within 24 hours	Yes
Other	Hb at 1-month F/U	hemoglobin (g/dL) at 1-month outpatient follow-up	1 month after discharge	Yes
Primary	Time to hemostasis		Immediately after invasive procedures	Yes
Secondary	Bleeding	TIMI major/minor bleeding within 24 hours	within 24 hours	Yes
Secondary	Hematoma	Hematoma within 24 hours	within 24 hours	Yes
Secondary	Retroperitoneal hematoma	Retroperitoneal hematoma within 24 hours	within 24 hours	Yes
Secondary	Pseudoaneurysm	Pseudoaneurysm within 24 hours	within 24 hours	Yes
Secondary	Vessel occlusion	Vessel occlusion within 24 hours (either 1 or 2); no palpable pulse; no flow on Doppler	within 24 hours	Yes
Secondary	Dissection	Dissection of access vessel within 24 hours (either 1 or 2); observed on angiography; symptomatic compromising distal flow	within 24 hours	Yes
Secondary	Surgical repair	Surgical repair within 24 hours	within 24 hours	Yes
Secondary	Vasovagal reaction	Vasovagal reaction (grade 3-4) within 24 hours	within 24 hours	Yes