Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT)

Seto, Arnold H.; Rollefson, William; Patel, Mitul; Suh, William M.; Tehrani, David M.; Nguyen, Jacqueline A.; Amador, Daniel G.; Behnamfar, Omid; Garg, Vinisha; Cohen, Mauricio G.

doi:10.4244/eij-d-18-00101

Cited by 14 publications

(10 citation statements)

References 13 publications

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“…In our study the hemostasis time was reduced by 3 hr from 225 to 42 min ( p < .001) with a similar reduction in time to termination of radial protocol. The reduction in hemostasis time is comparable to reported results with a different hemostatic pad, StatSeal 14,15 . Reduced compression time will improve patient comfort and facilitate cath lab logistics.…”

Section: Discussionsupporting

confidence: 76%

Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band

Pathan

Aijaz

Sheikh

et al. 2021

Cathet Cardio Intervent

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Objectives Primary objectives: to compare radial artery occlusion rate (RAO) after cardiac catheterization between catecholamine‐chitosan pad (InnoSEAL) and pneumatic compression device (PCD) and to compare difference in hemostasis time and radial monitoring termination time between two arms. Secondary objectives: to compare radial site bleeding and ease of use of two methods by cath‐lab technicians. Background Hemostatic pads may be an effective alternative to PCD with lesser chance of access site complications with advantage of shortened compression time. Methods Patients (N = 606) undergoing trans‐radial, diagnostic or interventional procedures were randomized to either InnoSEAL arm or PCD. RAO was assessed using US Duplex; performed 6–24 hr posthemostatic device removal. Time to hemostasis was recorded as per defined protocols. Ease of use among cath‐lab technicians was assessed through 5 point Likert scale. Results Data of 597 patients was analyzed (299 InnoSEAL, 298 PCD). RAO rate was 8.5% in InnoSEAL and 9.4% in PCD arm (p value >.05). The pooled median hemostasis time and time to termination of radial monitoring was 42 versus 225 min and 50 versus 240 min in InnoSEAL and PCD arms, respectively (p value: <.01). There was no difference in Grade I/II hematoma (InnoSEAL: 1.3% vs. PCD: 3.4%). InnoSEAL was marginally acceptable compared to PCD by technicians. Conclusion Hemostasis time is significantly shorter in InnoSEAL arm with reasonable acceptability to its usage among cath lab staff. RAO and bleeding complications are comparable between the arms. Based on our findings, it seems feasible to include Chitosan based hemostasis pad routinely in cath lab.

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Section: Discussionsupporting

confidence: 76%

Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band

Pathan

Aijaz

Sheikh

et al. 2021

Cathet Cardio Intervent

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“…We have recently demonstrated that the use of a potassium ferrate patch facilitates early TR band deflation at 66 min, compared with 113 min with the TR band alone. Notably, despite 41% of patients receiving less than 5,000 units of UFH, RAO rates were less than 1%, similar to other studies with short compression 1,4,5 …”

supporting

confidence: 87%

Heparin, compression, and radial artery occlusion: Less is more

Tehrani

Seto

2021

Cathet Cardio Intervent

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Key Points Radial artery occlusion is a function of anticoagulation, compression time, compression pressure, and vascular injury from sheath size and puncture attempts. This study showed that increased levels of anticoagulation during transradial cases is associated with a higher incidence of occlusive hemostasis, increasing the risk of radial artery occlusion. Reductions in compression time as made possible by adjunctive hemostatic patches may obviate the need for high doses of heparin.

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“…5 The combined use of transradial band (TRB) with a haemostatic device may allow ease of use with reduced haemostasis time. 6 Patent haemostasis is also likely to be achieved with the combined use of both devices and possibly improve radial artery patency with the added benefit of reduced bleeding complications. So far two trials have been undertaken that compared RCD alone with RCD plus catechol conjugated homeostasis pads.…”

Section: Open Accessmentioning

confidence: 99%

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)

2020

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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.

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Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT)

Abstract: The PFHP haemostatic patch facilitated early deflation of the TRB with a non-significant increase in forearm haematomas. Use of the PFHP may improve patient throughput and allow earlier discharge following transradial procedures.

Cited by 14 publications

References 13 publications

Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band

Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band

Heparin, compression, and radial artery occlusion: Less is more

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)

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