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Completed

NCT Number: NCT03298126

Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion

Coronary artery disease (CAD) is one of the major health concerns among other non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to determine the extent of disease in coronary arteries due to atherosclerosis. Among the two approaches for cardiac catheterization, trans-radial approach has gained more popularity than conventional trans-femoral approach over the past decade with availability of compression devices for radial artery that assures lesser risk of bleeding and hematoma and has translated into increased patient comfort and early mobility post procedure. Radial artery occlusion is a common complication of trans-radial procedures often ignored by the operator after procedure due to dual blood supply by ulnar artery. Although clinically silent usually, it necessitate the need of monitoring radial artery for patency because of risk of limited trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. , compression devices applied after sheath removal may be a contributing factor to radial artery occlusion because of selective pressure for extended time duration (3-4 hours). Various protocols have been developed to remove TR band by different institutions across the globe and have been tested to assess post procedure complications. To the best of what we know, there exists no standard protocol to deflate TR band. Also, the current protocol in practice at our institution has not been evaluated against other protocols that are followed in other institution across the globe claiming lesser post procedure complications. Hence, our aim was to test through a randomized trial whether our hospital standard protocol is non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser complication rate

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted for coronary angiography in specified period of study
  • patients who sign informed consent

Exclusion criteria

  • known radial artery occlusion
  • > 3 radial angiograms in the past
  • plan for AD- hoc PCI
  • on warfarin therapy
  • known bleeding diathesis or hypercoagulable state
  • contraindication to radial artery access such as hemodialysis fistula, mastectomy or localized infection

Treatment and study plan

TR BAND removal protocol

Procedure

To assess radial artery patency after specific protocol used as already described in previous section.

Other names: Ultrasound doppler, plethysmography

Primary outcomes

  1. Radial artery occlusion (RAO)

    Time frame: from TR band removal upto 24 hours of hospital stay of the patient

    Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms

Secondary outcomes

  1. Hematoma

    Time frame: from TR band removal upto 24 hours of hospital stay of the patient

    Patients in both arms were assessed for the presence of hematoma in the cannulated arm used for the angiography before and after the TR band removal. Hematoma were graded from grad 1-5 according to the extent of arm involvement as per standard EASY hematoma classification system.

  2. Re bleed

    Time frame: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient

    patients in both arms were assessed for any sign of major or minor bleeding from the punctured site, such as oozing, frank bleeding which required extra pressure to apply on the site to control it, or required extra amount of air to be inflated to control it. any such event was documented as Re bleed after the TR band application.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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