Not Yet RecruitingPhase 4ACTRN12621001644853

Safety of anticoagulation in elective colonoscopy

Safety of uninterrupted peri-procedural direct-acting oral anticoagulation during colonoscopy


Sponsor

Dr Nicholas Tutticci

Enrollment

200 participants

Start Date

Dec 1, 2021

Study Type

Interventional

Conditions

Summary

The aim of this study is to investigate if patients can safely continue their blood thinner medication for small polypectomies without any procedure related complications.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

  • Patients undergoing elective colonoscopy
  • Chronically anti-coagulated with DOACs (Apixaban/Dabigatran/Rivaroxaban)

Exclusion Criteria16

  • Individual characteristics:
  • o Concurrent antiplatelet therapy prescribed
  • o Discharge location distance from the hospital of greater than 100 kilometres
  • o Individuals unable to give consent
  • o Patients with renal impairment (defined as eGFR <45)
  • Continuation of anticoagulation is not advised:
  • o Prior peri-procedural bleeding requiring anticoagulation cessation/intervention/hospitalisation
  • Interruption to anticoagulation not recommended:
  • o Thromboembolic event in the preceding 3 months
  • o Active malignancy
  • Procedure planned to be performed by alternative clinician not participating in the study
  • Endoscopic factors:
  • o Emergency procedure
  • o Concurrent endoscopy being performed on same day
  • o Planned therapeutic procedure (i.e. large polypectomy/endo-mucosal resection/endoscopic submucosa dissection/dilatation)
  • o Expected high burden of polyps (i.e. known polyposis syndrome not yet completed clearance colonoscopy)

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Interventions

Guidelines for anticoagulation management universally recommend temporary cessation of direct-acting oral anti-coagulants (DOACs) prior to elective colonoscopy. These medications include: Apixaban (ei

Guidelines for anticoagulation management universally recommend temporary cessation of direct-acting oral anti-coagulants (DOACs) prior to elective colonoscopy. These medications include: Apixaban (either 5mg or 2.5mg taken twice a day), Dabigatran (150mg or 110mg taken twice a day) and Rivaroxaban (20mg or 15mg taken once a day). Our aim is to demonstrate non-inferiority of uninterrupted DOAC in terms of peri-procedural complications in patients on DOAC therapy for risk of thrombosis (intervention arm). The exact doses for each patient varies depending upon the indication for the medication as well as patient co-morbidities. These will not be dictated by the trial. To ensure standardization, all procedures in this study will be performed by three nationally accredited consultant Gastroenterologists including the study investigator or a senior endoscopy fellow under direct supervision. Day of the procedure: The endoscopist will be made aware that the patient is a participant of this study however will be blinded to the arm. The patient’s timing of cessation of anticoagulation will be confirmed by the admitting nursing staff and be recorded on a standard form. All colorectal polyps amenable to endoscopic removal at index colonoscopy as per clinical care will be removed using cold-snare polypectomy (CaptivatorTM Cold or SnareMaster Plus) or hot-snare (CaptivatorTM II). The transected polyp will be sucked into a trap or via the scope to the anus. The method of resection, i.e. hot versus cold, en-bloc versus piecemeal or the inject-and-resect technique using methylene blue with or without epinephrine will be at the discretion of the proceduralist. On average, an average colonoscopy is expected to take a total of 15-30 minutes. Intraprocedural bleeding is defined as bleeding persisting for greater than 60 seconds during the procedure requiring endoscopic intervention. Usual methods of controlling intra-procedural bleeding include application of clips, thermal treatment or injection of submucosal epinephrine. Routine prophylactic clip closure will follow current clinical practice at our facility where routine clip closure is performed for hot polypectomy sites but not cold polypectomy. If decision to proceed with clipping, this will be performed using Instinct® Endoscopic clip or ResolutionTM Clip. Patients will follow standard post procedure recovery in stages 1 and 2 in the unit. Written post-procedural instructions will be provided as per usual practice post colonoscopy on potential problems and contact details for advice.


Locations(1)

Queen Elizabeth II Jubilee Hospital - Coopers Plains

QLD, Australia

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ACTRN12621001644853


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