Effects of Ischemic Preconditioning After Aortic Clamping

NCT ID: NCT02254642

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2021-12-15

Brief Summary

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Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

Detailed Description

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Conditions

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Vascular Surgery Ischemia-reperfusion Ischemia Preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ischemic preconditioning arm

Patients will have the ischemic preconditioning protocol 1 hour before the aortic clamping.

Group Type EXPERIMENTAL

Ischemic preconditioning during aortic clamping

Intervention Type PROCEDURE

Ischemic preconditioning during aortic clamping

Control patients

Usual surgery assigned to control patients

Group Type OTHER

Procedure/Surgery: usual surgery

Intervention Type PROCEDURE

Procedure/Surgery: usual surgery

Interventions

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Ischemic preconditioning during aortic clamping

Ischemic preconditioning during aortic clamping

Intervention Type PROCEDURE

Procedure/Surgery: usual surgery

Procedure/Surgery: usual surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with an aortic aneurysm requiring open surgery (with no possibility of endovascular surgery)
* Patients who received clear information, with signed consent
* Patients 18 to 85 years

Exclusion Criteria

* Patients under guardianship
* No possibility to give the patients clear information (comprehension difficulties, emergency surgery)
* Pregnancy, lactation
* Hemodialysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Lejay, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Chirurgie Vasculaire, CH Jean Minjoz

Besançon, , France

Site Status

Service de Chirurgie Vasculaire, CHU le Bocage

Dijon, , France

Site Status

Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

Vantoux, , France

Site Status

Countries

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France

References

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Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type DERIVED
PMID: 36645250 (View on PubMed)

Other Identifiers

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5831

Identifier Type: -

Identifier Source: org_study_id

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