Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures

NCT02954029 | Unknown Phase 4 DMC

• 1 other identifier: ezClot1
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Puncture

Outcome Measures

Primary Outcomes (1)

• Time to hemostasis

  Immediately after invasive procedures

Secondary Outcomes (8)

• Bleeding

  within 24 hours

• Hematoma

  within 24 hours

• Retroperitoneal hematoma

  within 24 hours

• Pseudoaneurysm

  within 24 hours

• Vessel occlusion

  within 24 hours

Other Outcomes (2)

• Hb at discharge

  within 24 hours

• Hb at 1-month F/U

  1 month after discharge

Study Arms (4)

Study group (transradial cohort)

EXPERIMENTAL

device-assisted compression with ezClot pad

Device: ezClot (hemostasis pad); Device: Rotary compression device

Study group (transfemoral cohort)

EXPERIMENTAL

manual compression with ezClot pad

Device: ezClot (hemostasis pad)

Control group (transradial cohort)

ACTIVE COMPARATOR

Rotary compression device

Device: Rotary compression device

Control group (transfemoral cohort)

ACTIVE COMPARATOR

manual compression with BloodSTOP ix pad

Device: BloodSTOP ix pad

Interventions

ezClot (hemostasis pad) DEVICE

ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.

Study group (transfemoral cohort); Study group (transradial cohort)

BloodSTOP ix pad DEVICE

BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.

Control group (transfemoral cohort)

Rotary compression device 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 (transradial cohort); Study group (transradial cohort)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• patients undergoing invasive procedures via the radial or femoral arteries

You may not qualify if:

• congenital or acquired bleeding tendency
• platelet count \<50,000/ μL
• hypersensitivity to shrimps, lobsters or beetles

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 06511, South Korea

RECRUITING

Related Publications (10)

• 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.

  PMID: 21996385 BACKGROUND

• 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.

  PMID: 16908769 BACKGROUND

• 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.

  PMID: 16531876 BACKGROUND

• 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.

  PMID: 21518684 BACKGROUND

• 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.

  PMID: 22921708 BACKGROUND

• 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.

  PMID: 20506228 BACKGROUND

• 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.

  PMID: 26002786 BACKGROUND

• 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.

  PMID: 24496325 BACKGROUND

• 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.

  PMID: 16145231 BACKGROUND

• 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.

  PMID: 28742134 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

In-Ho Chae

CONTACT

ihchae@snubh.org

Si-Hyuck Kang

CONTACT

82-10-4011-5801; eandp303@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: November 3, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)