- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688879
Thrombolysis With Intra-arterial Urokinase
December 28, 2020 updated by: Being-Chuan Lin, Chang Gung Memorial Hospital
Thrombolysis With Intra-arterial Urokinase for Acute Superior Mesenteric Artery Occlusion: Outcome Analysis
Patients with acute superior mesenteric artery (SMA) occlusion were included in this study.
The clinical presentation and effect of the recanalization of the SMA was analyzed on follow-up angiography.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Thirteen patients with acute SMA occlusion who underwent intra-arterial urokinase thrombolysis between 2008 and 2020 were retrospectively evaluated.
Clinically, the abdominal pain and the effect of the SMA on angiography will be compared in response and non-response groups.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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TaoYuan City, Taiwan, 886
- Chang Gung memorial hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
13
Description
Inclusion Criteria:
- Clinical diagnosis of SMA occlusion
Exclusion Criteria:
- shock in the triage screening
- peritonitis
- 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
According to the degree of occlusion, 13 patients were divided into complete and incomplete groups.
Seven patients were complete occlusion and 6 patients were incomplete occlusion and all underwent thrombolysis with intra-arterial urokinase and the outcome was analysed..
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Under local anaesthesia, the right femoral artery was punctured in accordance with the Seldinger technique, and a 6-Fr sheath, 10 cm in length, was implanted.
Selective catheterization of the SMA was performed with 4-Fr catheter.
The SMA angiography was performed to identify the filling defect.
Thrombolysis was performed using a 5-Fr multiple-sideport infusion catheter (100cm with sideport of 7cm, 14 ports or 100cm with sideport of 15cm, 30 ports, Cook, Bloomington, IN, U.S.A).
The tip of the microcatheter was embedded in the thromboembolism, which was fragmented at the time of thrombolysis.
Thrombolysis was performed locally in the SMA with a bolus of urokinase
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombolysis with intra-arterial urokinase for acute superior mesenteric artery occlusion: Outcome analysis
Time Frame: Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase.
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Degree of patency and appearance of the SMA will be analyzed in the follow-up angiography.
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Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Being-Chuan Lin, Chang Gung Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bala M, Kashuk J, Moore EE, Kluger Y, Biffl W, Gomes CA, Ben-Ishay O, Rubinstein C, Balogh ZJ, Civil I, Coccolini F, Leppaniemi A, Peitzman A, Ansaloni L, Sugrue M, Sartelli M, Di Saverio S, Fraga GP, Catena F. Acute mesenteric ischemia: guidelines of the World Society of Emergency Surgery. World J Emerg Surg. 2017 Aug 7;12:38. doi: 10.1186/s13017-017-0150-5. eCollection 2017.
- Bjornsson S, Bjorck M, Block T, Resch T, Acosta S. Thrombolysis for acute occlusion of the superior mesenteric artery. J Vasc Surg. 2011 Dec;54(6):1734-42. doi: 10.1016/j.jvs.2011.07.054. Epub 2011 Sep 1.
- Tilsed JV, Casamassima A, Kurihara H, Mariani D, Martinez I, Pereira J, Ponchietti L, Shamiyeh A, Al-Ayoubi F, Barco LA, Ceolin M, D'Almeida AJ, Hilario S, Olavarria AL, Ozmen MM, Pinheiro LF, Poeze M, Triantos G, Fuentes FT, Sierra SU, Soreide K, Yanar H. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg. 2016 Apr;42(2):253-70. doi: 10.1007/s00068-016-0634-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
December 27, 2020
First Submitted That Met QC Criteria
December 28, 2020
First Posted (Actual)
December 30, 2020
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 28, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202000381B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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