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Trial record 60 of 291 for:    warfarin AND anticoagulation

Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation

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ClinicalTrials.gov Identifier: NCT02120170
Recruitment Status : Unknown
Verified April 2014 by Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 22, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital

Brief Summary:

There have been very limited evidence about the bleeding complication during colon polypectomy for the patients taking warfarin.

This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.

The enrolled subjects are the patients who take warfarin for high thromboembolism risk and should take heparin bridging therapy during colon polypectomy instead of temporary stopping warfarin. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy.

The primary endpoint is to compare the rate of delayed bleeding between two groups.


Condition or disease Intervention/treatment Phase
Colon Polyp Procedure: Colon polypectomy Not Applicable

Detailed Description:

The American guideline have recommended that if the patient with low risk of thromboembolism, warfarin consumption can be quit 3~5 days before colon polypectomy and resume within 24 hours after polypectomy. However, if the patient were high risk of thromboembolism, the patient should take heparin bridging therapy during temporal quit of warfarin consumption for colon polypectomy. There have been very limited evidences about the bleeding complication during colon polypectomy for the patients with warfarin taking.

Moreover, there have been lack of evidence that how to prevent the bleeding complication in the patients with high risk of thromboembolism who should take heparin bridging therapy during temporal stopping of warfarin for colon polypectomy.

This study is aimed to analyse the effect of prophylactic hemo-clipping during colon polypectomy for the patients with warfarin consumption.

The investigators will enroll the subjects who should take heparin bridging therapy (quit warfarin 3~5 days before colon polypectomy and check the INR, if the INR <2, heparin or low molecular heparin should be start. If the INR <1.5 on the day before colon polypectomy, the patient will undergo bowel preparation and colon polypectomy. Warfarin will resume within 24 hour after polypectomy) after quit warfarin for during colon polypectomy over 19 years old.

Exclusions are as follow; patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies. The investigators will randomize into two groups; the patient enrolled into group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding. And the patients enrolled into group 2 will be performed hemoclipping only for the lesion of immediate bleeding during colon polypectomy. Including polyps for colon polypectomy are 6~ 20 mm size and polypectomy procedure is defined as EMR after injection with blended electrical current.

The lesion which immediate bleeding is occurred during the polypectomy will be performed hemoclipping irrespective of group and will not be counted as delayed bleeding even though delayed bleeding is occurred on this lesion.

The primary endpoint is to compare the rate of delayed bleeding between two groups. The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding.

This study will be performed during 3 years after 1st patient enrollment and the target size of enrollment is 356 (176 in each group).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Prophylactic Clip Application for Colon Polypectomy in Patients With Anticoagulation: Prospective Randomized Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hemoclipping during colon polypectomy for all lesion
The enrolled patients of group 1 will be performed hemoclipping for all polypectomy lesion irrespective of the presence of immediate bleeding.
Procedure: Colon polypectomy
No Intervention: No hemoclipping if there were no bleeding during polypectomy
The patients of group 2 will be performed hemoclipping only for the immediate bleeding during colon polypectomy



Primary Outcome Measures :
  1. Number of participants with delayed bleeding [ Time Frame: Bleeding within 30 days after colon polypectomy ]
    The primary endpoint is to compare the rate of delayed bleeding between two groups.


Secondary Outcome Measures :
  1. Number of successful bleeding control after hemoclipping for immediate bleeding in the patients with warfarin. [ Time Frame: Bleeding during the procedure ]
    The secondary endpoint is to analyse the effect of hemoclipping for immediate bleeding and will be measured as successful hemostasis rate of hemoclipping. There has limited evidence about the efficacy of hemoclipping for the immediate bleeding during colon polypectomy in the patients with anticoagulation


Other Outcome Measures:
  1. Cut-off value of resuming timing of warfarin after colon polypectomy [ Time Frame: Within 1 week after polypectomy ]
    The guideline recommended warfarin resuming within 24 hours after colon polypectomy, But there is very limited evidence about safe timing of warfarin resuming regarding the bleeding complication.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects who should take heparin bridging therapy after quit warfarin 3~5 days before colon polypectomy because of high risk of thromboembolism - AF with valvular disease, AF with mechanical valve, AF with CHF, EF <35%, AF with previous thromboembolism, AF with DM and HTN, AF with old age(>75),

Exclusion Criteria:

  • patients who don't have to take bridging heparin therapy after quit warfarin, patients have low a platelet count (<80,000/mm3), patients who take anti-platelet agents, patients who have GI malignancies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120170


Contacts
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Contact: HYUN GUN KIM, MD.,PhD. 8227099852 medgun@schmc.ac.kr

Locations
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Korea, Republic of
Soonchunhyang University Hospital Not yet recruiting
Seoul, Korea, Republic of, 140-743
Contact: Hyun Gun Kim, MD.,PhD.    8227099852    medgun@schmc.ac.kr   
Principal Investigator: Hyun Gun Kim, MD.,PhD.         
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: Hyun Gun Kim, MD.,PhD. Soonchunhyang University Hospital

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Responsible Party: Hyun Gun, Kim. M.D., Ph.D., Associate professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02120170     History of Changes
Other Study ID Numbers: CLIPO
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Keywords provided by Hyun Gun, Kim. M.D., Ph.D., Soonchunhyang University Hospital:
Hemoclip, Heparin bridging therapy, colon polypectomy, warfarin
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical