Dataset Information

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).

ABSTRACT:

Introduction

About 2%-30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes.

Methods and analysis

It will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7?months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. ?² test will be used to compare the categorical outcomes between two arms and student's t-test for continuous outcomes. A p value of <0.05?will be considered significant.

Ethics and dissemination

Ethical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications.

Trial registration number

NCT04380883; Pre-results.

SUBMITTER: Aijaz S

PROVIDER: S-EPMC7759964 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

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).

Aijaz Saba S Sheikh Sana S Pathan Asad A

BMJ open 20201223 12

<h4>Introduction</h4>About 2%-30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-infer ...[more]

PMID: 33361166

Similar Datasets

Project description:AimCoronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction.MethodsAll patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale.ResultsA total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 (n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 (n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 (p = 0.01).ConclusionA protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

Dataset Information

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).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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).

Similar Datasets

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