NCT04688879

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

December 27, 2020

Last Update Submit

December 28, 2020

Conditions

Arterial Occlusion Mesenteric Artery Superior

Keywords

intra-arterial urokinase

Outcome Measures

Primary Outcomes (1)

  • 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.

    Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase.

Study Arms (1)

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..

Procedure: intra-arterial urokinase thrombolysis

Interventions

intra-arterial urokinase thrombolysisPROCEDURE

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

According to the degree of occlusion, 13 patients were divided into complete and incomplete groups.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

13

You may qualify if:

  • Clinical diagnosis of SMA occlusion

You may not qualify if:

  • shock in the triage screening
  • peritonitis
  • \. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung memorial Hospital

Taoyuan, 886, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 28794797RESULT

  • 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.

    PMID: 21889287RESULT

  • 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.

    PMID: 26820988RESULT

Study Officials

  • Being-Chuan Lin

    Chang Gung Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor of the Trauma & Emergency Surgery

Study Record Dates

First Submitted

December 27, 2020

First Posted

December 30, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)