An interventional study of TR BAND removal protocol in Radial Artery Occlusion, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-02.
Sponsored by Aga Khan University · Not applicable, Interventional, and Other
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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
230 studies on the registry are indexed under Arterial Occlusive Diseases; 27 are open to participants now.
This study's enrollment of 100 is below the median of 184 across 157 interventional studies indexed under Arterial Occlusive Diseases.
Browse Arterial Occlusive Diseases studies →Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
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In this group, air removal from TR band was initiated after 2 hours of TR band application. 3 ml of air was removed periodically at an interval of 15 minutes until all the air is eliminated from the band. In case of bleeding or hematoma while deflating air, 4 ml of air was re-injected and observed for 30 minutes until next attempt was made to deflate the band. The data including the attempts made at deflating TR band, time and amount of air injected along with the response to each deflation i.e. occurrence of bleeding or hematoma was noted down in the proforma
Procedure: TR BAND removal protocol
In this group deflation was initiated after 2 hours of TR band application as described by Cohen and Alfonso. \[6\] 5 ml of air was deflated at first attempt. Next attempt was carried out after 15 minutes in which further 5 ml was removed. After 15 minutes, the remaining 2 ml of air was released from the band. In case of bleeding or hematoma at any attempt, 6 ml air was re-injected and interval for 15 minutes taken to attempt further air deflation. All the attempts and its response were recorded in the proforma filled out by the assessor.
Procedure: TR BAND removal protocol
To assess radial artery patency after specific protocol used as already described in previous section.
Also known as: Ultrasound doppler, plethysmography
Radial artery occlusion (RAO)
Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms
Time frame: from TR band removal upto 24 hours of hospital stay of the patient
Hematoma
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.
Time frame: from TR band removal upto 24 hours of hospital stay of the patient
Re bleed
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.
Time frame: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient
Plan to share: No
Ran from Feb 2017 to primary completion in Jul 2017, 5 months.
Of 47 non-industry interventional studies with no phase under Arterial Occlusive Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 37. This study's 5 months is below that.
Counting every sponsor, half of 56 studies reached it within 27 months; a quarter within 14 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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