Arterial Occlusion Mesenteric Artery SuperiorNCT04688879
Thrombolysis With Intra-arterial Urokinase
An observational study of Arterial Occlusion Mesenteric Artery Superior, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Occlusion Mesenteric Artery Superior
- What is being tested?
- intra-arterial urokinase thrombolysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 13
Who may be able to join
- Clinical diagnosis of SMA occlusion
Who cannot join
- shock in the triage screening
- peritonitis
- 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- intra-arterial urokinase thrombolysis
- Keywords
- intra-arterial urokinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial urokinase thrombolysisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: Procedure: intra-arterial urokinase thrombolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombolysis with intra-arterial urokinase for acute superior mesenteric artery occlusion: Outcome analysis
Degree of patency and appearance of the SMA will be analyzed in the follow-up angiography.
Measured: Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusion Mesenteric Artery SuperiorStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Being-Chuan Lin, Chang Gung Memorial Hospital
- Investigators
- Being-Chuan Lin, Study director, Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688879
- Sponsor's protocol ID
- 202000381B0
- Status last verified
- Dec 2020
- First submitted
- 27 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28794797Bjornsson 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.
PubMed 21889287Tilsed 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.
PubMed 26820988
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombolysis With Intra-arterial Urokinase for Acute Superior Mesenteric Artery Occlusion: Outcome Analysis
- ClinicalTrials.gov ID
- NCT04688879
- Acronym / sponsor ID
- 202000381B0
- Keywords
- intra-arterial urokinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| According to the degree of occlusion, 13 patients were divided into complete and incomplete groups. | – | Procedure: intra-arterial urokinase thrombolysisSeven patients were complete occlusion and 6 patients were incomplete occlusion and all underwent thrombolysis with intra-arterial urokinase and the outcome was analysed.. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 13
Key inclusion criteria (1 listed)
- Clinical diagnosis of SMA occlusion
Key exclusion criteria (3 listed)
- shock in the triage screening
- peritonitis
- 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial urokinase thrombolysisUnder 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 | Procedure or surgery | According to the degree of occlusion, 13 patients were divided into complete and incomplete groups. |
Primary outcome
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.
Degree of patency and appearance of the SMA will be analyzed in the follow-up angiography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Results publication: PubMed 28794797Bala 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.
- Results publication: PubMed 21889287Bjornsson 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.
- Results publication: PubMed 26820988Tilsed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Being-Chuan Lin study director
Chang Gung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Occlusion Mesenteric Artery Superior, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688879, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.