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

IntroductionAbout 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 analysisIt 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. χ2 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 disseminationEthical 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 numberNCT04380883; Pre-results.

Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers

“…The surface of the platelets is negatively charged and is attracted by the positive charge of the chitosan, thus encouraging the formation of the clot when the chitosan comes into contact with the blood [ 29 , 30 ]. Previously, the hemostatic efficacy at the arterial vascular access site of other chitosan-based hemostatic pads as an adjunct to mechanical compression was evaluated [ 31 , 32 , 33 , 34 , 35 , 36 ]. However, no data are available on Axiostat ® .…”

Mussel‐inspired biomaterials: From chemistry to clinic

“…This mechanism is independent of the human blood coagulation system and thereby is expected to excel other fibrin‐based sealants when it comes to dealing with patients with the disorder in normal blood coagulation. To date, this FDA‐approved pad has been subjected to different single and multi‐center open‐label randomized controlled clinical trials in high‐income economy countries such as South Korea, as well as lower‐middle‐income countries such as Pakistan 322,323 . In 2020, Aijaz et al 323 studied the efficacy of InnoSEAL pad in a combination with the transracial band (TRB) on 714 randomly selected adult patients to enhance hemorrhage and better control bleeding.…”

“…To date, this FDA‐approved pad has been subjected to different single and multi‐center open‐label randomized controlled clinical trials in high‐income economy countries such as South Korea, as well as lower‐middle‐income countries such as Pakistan. 322 , 323 In 2020, Aijaz et al 323 studied the efficacy of InnoSEAL pad in a combination with the transracial band (TRB) on 714 randomly selected adult patients to enhance hemorrhage and better control bleeding. Their findings justify a significant improvement of this combinative method in terms of ease of use, short hemostasis time, and less discomfort for patients.…”