Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients
1 other identifier
interventional
286
0 countries
N/A
Brief Summary
One of the well-known of complications post colonic polypectomy is bleeding usually occuring in the 2-week period following the procedure. Patients treated with oral anticoagulation (e.g. Warfarin) are a special and challenging patient group due to the need on the one hand to prevent thromboembolic events, and on the second hand to minimize the risk of post-polypectomy bleeding. Current practice guidelines recommend holding Warfarin treatment while bridging with LMW Heparin while resuming Warfarin treatment following the procedure. This practice was found to be associated with a much higher rate of bleeding compared with continuing Warfarin in a recent prospective trial in pacemaker transplanted patients. The fact that most post-polypectomy bleeding occurs within the 2-week period further questions the current practice of periprocedural bridging therapy. the investigators therefore hypothesize that patients with continuous Warfarin treatment may have similar post-polypectomy bleeding rates compared to patients receiving bridging therapy with LMW Heparin. This is a multicenter single-blinded prospective randomized trial comparing small post-polypectomy (polyps\<10mm) bleeding rates between two groups of patients: Continuous therapy with Warfarin, vs. LMW Heparin therapy while withholding Warfarin therapy (current practice).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 2, 2015
February 1, 2015
2 years
February 24, 2015
February 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Post-polypectomy major bleeding rate
Delayed major GI-bleeding
2 weeks
Secondary Outcomes (3)
immediate post-polypectomy bleeding
up to 6 hours
Post-polypectomy major bleeding rate
2 weeks
Thromboembolic events
30 days
Study Arms (2)
Continued Warfarin
EXPERIMENTALcontinuous Warfarin therapy (aiming for therapeutic INR: 2-3) will be given throughout the study
LMW Heparin
ACTIVE COMPARATOREnoxaparin 1mg/kg SC bid (adjusted to renal function) will be given 5 days before the colonoscopy while withholding therapy with Warfarin. The day after procedure Warfarin therapy will be added, and Enoxaparin stopped when therapeutic INR will be reached
Interventions
Eligibility Criteria
You may qualify if:
- Patients at moderate-high risk of VTE
- Patient aged 40-75 undergoing colonoscopy
- On warfarin therapy
You may not qualify if:
- Pregnancy
- Known Polyps \> 10 mm
- Baseline Anemia \< 10 gr%
- NOACs based anticoagulation
- Concomitant Mandatory Aspirin therapy (in 6 months period following ACS)
- Dual antiplatelet therapy
- Known bleeding diathesis
- Severe hepatic or renal impairment
- Previous history of procedure related major bleeding
- History of noncompliance to medical therapy
- Prior HIT
- Included in another clinical trial
- Inability to comply with written daily reporting on dedicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Rambam Health Care Campuscollaborator
- Carmel Medical Centercollaborator
- Soroka University Medical Centercollaborator
- Tel Aviv Medical Centercollaborator
Related Publications (3)
ASGE Standards of Practice Committee; Anderson MA, Ben-Menachem T, Gan SI, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Lichtenstein DR, Maple JT, Shen B, Strohmeyer L, Baron T, Dominitz JA. Management of antithrombotic agents for endoscopic procedures. Gastrointest Endosc. 2009 Dec;70(6):1060-70. doi: 10.1016/j.gie.2009.09.040. Epub 2009 Nov 3. No abstract available.
PMID: 19889407BACKGROUNDBirnie DH, Healey JS, Wells GA, Verma A, Tang AS, Krahn AD, Simpson CS, Ayala-Paredes F, Coutu B, Leiria TL, Essebag V; BRUISE CONTROL Investigators. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013 May 30;368(22):2084-93. doi: 10.1056/NEJMoa1302946. Epub 2013 May 9.
PMID: 23659733RESULTHoriuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PMID: 24125514RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, IBD Unit, Institute of Gastroenterology and Liver Diseases
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 2, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2017
Study Completion
July 1, 2017
Last Updated
March 2, 2015
Record last verified: 2015-02