Combination of InnoSEAL Plus TR Band Compared to TR Band Alone

NCT04380883 | Completed

• 1 other identifier: InnoSEAL II
• Study Type: interventional
• Target: 714
• Locations: 1 country
• Sites: 1

Brief Summary

Angiography or angioplasty are commonly now done through inserting the device through radial artery in hand i.e. trans-radial procedures. It is reported that between 2-30% of these procedures get complicated by radial artery occlusion (RAO) which limit future use of this site for similar procedures if needed. It is important to control the arterial bleeding after the procedure completion while maintaining radial arterial flow appears to be an important factor in reducing RAO (patent hemostasis). Currently the most frequently employed method for hemostasis following trans-radial procedures is a compression device (RCD) such as TransRadial Bands (TRB). But TRB takes hours to achieve hemostasis and causes discomfort to the patients and longer time to discharge. Hemostatic pads offer an alternative to RCD where overall compression time is inherently low and patent hemostasis can possibly be achieved. The combined use of TR band with a hemostatic device may allow ease of use with reduced hemostasis time. The trial aims to test the hypothesis that compared to TR band (TRB) alone, catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.) used in conjunction with TRB (InnoSEAL+TRB)is nearly as good as TRB alone in terms of the outcomes like RAO and hematoma.

Conditions

Radial Artery Occlusion; Hematoma

Keywords

radial artery occlusion; access site outcomes; hemostatic patch

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Access site combined outcomes

  Proportion of patients with RAO and/or hematoma of any grade. 1. Radial artery occlusion: Radial artery will be defined as occluded if reverse Barbeau's test shows absence of flow on pulse oximetry just after the removal of the TR band in both groups.In patients identified to have RAO, findings will be confirmed using UltraSound (US) Duplex using color flow with pulse wave imaging within 24 hours of the radial procedure.US Duplex will be performed during the index hospital stay. 2. Radial Hematoma: Radial artery site will be assessed for presence of hematoma at the end of hemostasis protocol. Hematoma will be marked if present, and graded according to categories of I-IV. Hematomas grade II-IV will be considered significant.

  within 24 hours

Secondary Outcomes (5)

• Ease of use

  Upto 30 weeks

• Total compression time:

  within 24 hours

• Total observation time:

  within 24 hours

• Time to hospital discharge: (For daycare patients only)

  within 24 hours

• Patient discomfort:

  within 24 hours

Study Arms (2)

InnoSEAL+TRB

EXPERIMENTAL

InnoSEAL is a hemostatic patch which will be applied along with TRB to control bleeding from access site

Device: InnoSEAL+TRB

TRB alone

ACTIVE COMPARATOR

Device: TRB alone

Interventions

InnoSEAL+TRB DEVICE

InnoSEAL is a catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.). Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact. It is intended for use under the care of a healthcare professional. The dressing is indicated for the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes. TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. We will apply InnoSEAL and TRB together.

InnoSEAL+TRB

TRB alone DEVICE

TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. It will be the comparing arm.

TRB alone

Eligibility Criteria

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

You may qualify if:

• Adult patients of both gender undergoing coronary procedure using trans radial approach (diagnostic or PCI) will be included
• Both elective and hemodynamically stable, acute coronary syndrome (ACS) patients will be included.

You may not qualify if:

• Sheath larger than 6F
• IV Heparin or GP 2b/3a inhibitors continued after the procedure
• Ongoing anticoagulation with Warfarin or Rivaroxaban or INR \> 3
• Ipsilateral AV fistula
• Barbeau's Class D
• History of RAO at baseline
• Patients unable to give consent due to clinical instability or sedation.

Sponsors & Collaborators

• Tabba Heart Institute: lead

Study Sites (1)

Tabba Heart Institute

Karachi, Sindh, 75950, Pakistan

Location

Related Publications (1)

• Aijaz S, Sheikh S, Pathan A. Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol). BMJ Open. 2020 Dec 23;10(12):e042101. doi: 10.1136/bmjopen-2020-042101.

  PMID: 33361166 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases; Hematoma

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 8, 2020
• Study Start: June 3, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

PA (1)