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    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-001584-36
    Sponsor's Protocol Code Number:2014-03-11
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2016-001584-36
    A.3Full title of the trial
    Is high oxygen concentration a riskfactor for postoperative complications?
    A prospective, randomized, singel blinded study in elderly patients undergoing vascular surgery
    Är hög syrgaskoncentration en riskfaktor för postoperativa komplikationer?
    En prospektiv, randomiserad, enkelblind studie hos äldre patienter som genomgår kärlkirurgi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is high oxygen concentration a riskfactor for postoperative complications?
    A prospective, randomized singel blinded study in elderly patients undergoing vascular surgery
    Är hög syrgaskoncentration en riskfaktor för postoperativa komplikationer?
    En prospektiv, randomiserad enkelblind studie hos äldre patienter som genomgår kärlkirurgi
    A.4.1Sponsor's protocol code number2014-03-11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitetssjukhuset Örebro
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportForskningskommittéen Örebro (Nyckelfonden)
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitetssjukhuset Örebro, USÖ
    B.5.2Functional name of contact pointANIVA-kliniken, USÖ
    B.5.3 Address:
    B.5.3.1Street AddressUniversitetssjukhuset Örebro
    B.5.3.2Town/ cityÖrebro
    B.5.3.3Post code701 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+4619602 10 00
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Medicinsk Oxygen AGA
    D.2.1.1.2Name of the Marketing Authorisation holderAGA AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSyrgas
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number< 30%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Medicinsk Oxygen AGA
    D.2.1.1.2Name of the Marketing Authorisation holderAGA AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSyrgas
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number to >50%
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Elective vascular surgery (peripheral vascular and aortic surgery)
    Elektiva kärlkirurgiska ingrepp (perifierkärl och aorta kirurgi)
    E.1.1.1Medical condition in easily understood language
    Planned vascular surgery
    Planerade kärlkirurgiska ingrepp
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can a high oxygen concentration in inhaled air result in increased morbidity /mortality< 30 days in patients undergoing vascular surgeries?
    Kan en hög syrgaskoncentration i inandningsluften leda till ökad morbiditet/mortalitet <30 dagar hos patienter som genomgår kärlkirurgiska operationer?
    E.2.2Secondary objectives of the trial
    Is there a correlation between postoperative cognitive dysfunction in elderly and inspired oxygen concentration?

    Have increased reactive oxygen species (ROS) production during elevated oxygen supply any impact on morbidity?

    Can a low content of antioxidants in blood contribute to increased risk of perioperative complications during oxygen supply?
    Finns det ett samband mellan postoperativ kognitiv dysfunktion hos äldre och inspiratorisk syrgaskoncentration?

    Har ökad reactive oxygen species (ROS) produktion vid ökad syrgastillförsel någon betydelse för morbiditet?

    Kan en låg halt av antioxidanter i blodet bidra till ökad risk för perioperativa komplikationer vid syrgas tillförsel?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients undergoing elective vascular surgery on arteries (peripheral vascular and aortic surgery). Elective surgery means that there is no medical need for surgery within 24 hours.
    - > 65 years old
    - No language or communication difficulties
    - Willing to participate in the study
    - Patienter som opereras för elektiva kärlkirurgiska ingrepp på artärer (perifierkärl och aorta kirurgi) Med elektiv kirurgi menas att det ej finns medicinskt behov av kirurgi inom 24 timmar.
    - > 65 år gamla
    - Inga språk eller kommunikations svårigheter
    - Villiga att delta i studien
    E.4Principal exclusion criteria
    Patients with chronic obstructive pulmonary disease or other lung diseases that require oxygen therapy at rest.
    Patients undergoing carotid surgery
    Patients scoring < 24p on the preoperative MMT (when applicable)
    Patienter som har kronisk obstruktiv lungsjukdom/andra lungsjukdomar som innebär syrgasbehandling i vila.
    Patienter som genomgår carotis kirurgi
    Patienter som får < 24p på det preoperativa MMT (när kognitiv funktion görs)
    E.5 End points
    E.5.1Primary end point(s)
    Composite morbidity / mortality < 30 days after vascular surgery.
    Composite primary endpoint: One or more of the following postoperative complications including:
    * Myocardial infarction or damage: ECG changes or symptoms and / or typical troponin I change as in myocardial damage (first rising then falling troponin)
    * Heart Failure: p-BNP> 600 or treatment requiring
    * Stroke / TIA in unity with international definition
    * Renal insufficiency: RIFLE criteria with at least doubling of creatinine / urea, or a decrease in GFR> 50% or urine production <300 ml / 24 h or postoperative needs of dialysis
    * Wound infection, pneumonia, urinary tract infection or other infections that require antibiotic treatment
    * Postoperative respiratory therapy / noninvasive ventilation (unexpected)
    * Re-surgery due to bleeding or other surgical complications
    * Serious coagulation disorder that requires pharmacological action including massive bleeding (> 4 units e-conc / 24t)
    * Deep vein thrombosis / pulmonary embolism: clinical suspicion and radiological diagnosis
    * Other complications that are considered by the investigator as serious or delays time to departure from hospital
    * Re-hospitalization due to complications
    * Deaths within 30 days
    Composite morbiditet/mortaliteten <30 dagar efter kärlkirurgi. Composite primär endpoint: En eller flera av nedanstående postoperativa komplikationer inklusive:
    *hjärtinfarkt eller skada: EKG förändring eller symptom och/eller typisk troponin I förändring som vid hjärtmuskelskada (först stigande sedan fallande troponin),
    *hjärtsvikt: p-BNP > 600 eller behandlingskrävande
    *stroke/TIA: i enighet med internationell definition
    *njurinsufficiens: RIFLE kriteria med minst fördubbling av krea/urea, eller minskning av GFR>50% eller urinproduktion < 300 ml/24 t eller postoperativt dialys behov
    *sårinfektion, lunginflammation, urinvägsinfektion eller andra infektioner som kräver antibiotika behandling
    *postoperativ respirator behandling/noninvasiv ventilation (oförväntad)
    *reoperation pga blödning eller andra kirurgiska komplikation
    *allvarlig koagulations rubbning som kräver farmakologisk åtgärd inklusive massiv blödning(>4 enheter e-konc/24t)
    *djup ventrombos/lungemboli: klinisk misstanke och radiologisk diagnos
    *övriga komplikationer som betraktas av prövare som allvarlig eller fördröjer hemgång
    *återinläggning på sjukhus pga komplikation
    *dödsfall inom 30 dagar
    E.5.1.1Timepoint(s) of evaluation of this end point
    < 30 days after vascular surgery
    < 30 dagar efter kärlkirurgi
    E.5.2Secondary end point(s)
    Cytokine concentration (several pro- and anti-inflammatory cytokines are measured in blood and peritoneal fluid)
    Total ROS production in blood
    Cognitive dysfunction
    Plasma antioxidant concentration
    Time to discharge
    Other complications between 30 days -1 years after surgery.
    Cytokin koncentration (flera pro- och anti-inflammatoriska cytokiner mäts i blod och peritoneal vätska),
    Total ROS produktion i blod
    Kognitiv dysfunktion
    Antioxidant koncentration i plasma
    Tid till hemgång
    Övriga komplikationer mellan 30 dagar -1 år efter kirurgin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken preoperatively and postoperatively after 4, 24 and 48 hours
    Cognitive function tests will be performed pre-operatively and postoperatively after 24 hours, 7 days and 30 days.
    Postoperative complications between 30 days - 1 year after surgery.
    Blodprover tas pre-operativt samt postoperativt efter 4, 24 och 48 timmar
    Kognitiva funktionstest pre-operativt och postoperativt efter 24 timmar, 7 dagar samt 30 dagar.
    Postoperativa komplikationer mellan 30 dagar - 1 år efter kirurgin.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Hög syrgasfraktion, > 50%
    High oxygen fraction,> 50%
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will end when the last patient has completed the 12 month follow-up.
    To minimize the potential damage that a low-normal oxygen saturation in the blood could lead to, an independent committee will review the results continuously.
    Thus, this project can be terminated prematurely before all patients are recruited if the risk of harm exceeds the benefit for patients with either low-normal or high concentration of oxygen .
    Studien avslutas när den sista patienten genomfört uppföljningen efter 12 månader.
    För att minimera den eventuella skada som en låg-normal syrgas saturation i blodet kan innebära kommer en oberoende kommitté att granska resultatet kontinuerligt. Därmed kan detta projekt avslutas i förtid innan alla patienter är rekryterade, i det fallet att risken för skada överstiger nyttan för patienterna, med antingen låg-normal eller hög koncentration av syrgas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment following vascular surgeries
    Normal behandling efter vaskulära kirurgiska ingrepp
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-27
    P. End of Trial
    P.End of Trial StatusOngoing
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