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Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery (CARVASAXe)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120405
First Posted: May 11, 2010
Last Update Posted: June 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
BIOMNIS Central laboratory
MONITORING FORCE GROUP CROs
INFERENTIAL
Information provided by (Responsible Party):
Air Liquide Santé International
Results First Submitted: March 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Screening
Conditions: Elevated Cardiac Risk
Coronary Arteries Disease Risk
Interventions: Drug: Xenon
Drug: Sevoflurane

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Participant Flow:   Overall Study
    Xenon   Sevoflurane
STARTED   298   302 
COMPLETED   271   269 
NOT COMPLETED   27   33 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
Sevoflurane 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
Total Total of all reporting groups

Baseline Measures
   Xenon   Sevoflurane   Total 
Overall Participants Analyzed 
[Units: Participants]
 295   295   590 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.6  (10.3)   71.2  (10.2)   70.9  (10.2) 
Gender 
[Units: Participants]
     
Female   57   52   109 
Male   238   243   481 
Region of Enrollment 
[Units: Participants]
     
France   295   295   590 
Participants with Baseline Cardiac Troponin (Central Laboratory) 
[Units: Participants]
     
> 99th percentile   26   26   52 
≤ 99th percentile   269   269   538 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants With Myocardial Necrosis (MN)   [ Time Frame: 3 Postoperative Days ]

Measure Type Primary
Measure Title Number of Participants With Myocardial Necrosis (MN)
Measure Description Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)
Time Frame 3 Postoperative Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 273   261 
Number of Participants With Myocardial Necrosis (MN) 
[Units: Participants]
 57   54 


Statistical Analysis 1 for Number of Participants With Myocardial Necrosis (MN)
Groups [1] All groups
Statistical Test Type [2] Non-Inferiority or Equivalence
Statistical Method [3] Difference of proportion
P Value [4] 0.0052
Difference of proportion [5] 0.19
95% Confidence Interval -6.70 to 7.07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
 

The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc < 10%.

As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included.

[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)   [ Time Frame: 3 Postoperative days ]

Measure Type Secondary
Measure Title Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
Measure Description At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
Time Frame 3 Postoperative days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories) 
[Units: Participants]
 27   25 


Statistical Analysis 1 for Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Difference of proportion
P Value [4] 0.7715
Difference of proportion [5] 0.68
95% Confidence Interval -3.90 to 5.25
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Secondary:   Number of Participants With Myocardial Infarction (MI)   [ Time Frame: 3 Postoperative Days ]

Measure Type Secondary
Measure Title Number of Participants With Myocardial Infarction (MI)
Measure Description Patients with Confirmed Myocardial Infarction (MI) by the Investigators
Time Frame 3 Postoperative Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants With Myocardial Infarction (MI) 
[Units: Participants]
 5   3 


Statistical Analysis 1 for Number of Participants With Myocardial Infarction (MI)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Difference of proportion
P Value [4] 0.4763
Difference of proportion [5] 0.68
95% Confidence Interval -1.19 to 2.54
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Secondary:   Number of Participants With Cerebro-Vascular Event   [ Time Frame: 3 postoperative days ]

Measure Type Secondary
Measure Title Number of Participants With Cerebro-Vascular Event
Measure Description Patients with Cerebro-Vascular Event in the FAS
Time Frame 3 postoperative days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants With Cerebro-Vascular Event 
[Units: Participants]
 2   3 


Statistical Analysis 1 for Number of Participants With Cerebro-Vascular Event
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Difference of proportion
P Value [4] 0.6533
Difference of proportion [5] -0.34
95% Confidence Interval -1.82 to 1.14
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Secondary:   Number of Participants With Life-Threatening Arrhythmia   [ Time Frame: 3 Postoperative Days ]

Measure Type Secondary
Measure Title Number of Participants With Life-Threatening Arrhythmia
Measure Description Patients with Life-Threatening Arrhythmia in the FAS
Time Frame 3 Postoperative Days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants With Life-Threatening Arrhythmia 
[Units: Participants]
 2   0 


Statistical Analysis 1 for Number of Participants With Life-Threatening Arrhythmia
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Difference of proportion
P Value [4] 0.1559
Difference of proportion [5] 0.68
95% Confidence Interval -0.26 to 1.61
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



6.  Secondary:   Number of Participants Who Died From Cardiac Origin   [ Time Frame: 3 postoperative days ]

Measure Type Secondary
Measure Title Number of Participants Who Died From Cardiac Origin
Measure Description No patient died from a cardiac cause during the 3 postoperative days.
Time Frame 3 postoperative days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants Who Died From Cardiac Origin 
[Units: Participants]
 0   0 

No statistical analysis provided for Number of Participants Who Died From Cardiac Origin



7.  Secondary:   Number of Participants With Composite Endpoint   [ Time Frame: 3 postoperative days ]

Measure Type Secondary
Measure Title Number of Participants With Composite Endpoint
Measure Description Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
Time Frame 3 postoperative days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Number of Participants With Composite Endpoint 
[Units: Participants]
 61   56 


Statistical Analysis 1 for Number of Participants With Composite Endpoint
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Difference of proportion
P Value [4] 0.6056
Difference of proportion [5] 1.69
95% Confidence Interval -4.74 to 8.13
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Secondary:   Systolic Blood Pressure (SBP)   [ Time Frame: From pre-induction to recovery of anesthesia ]

Measure Type Secondary
Measure Title Systolic Blood Pressure (SBP)
Measure Description Repeated Systolic Blood Pressure measurements during the perioperative period
Time Frame From pre-induction to recovery of anesthesia  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 295   295 
Systolic Blood Pressure (SBP) 
[Units: Mm Hg]
Mean (Standard Deviation)
   
Baseline   146.1  (21.6)   147.3  (23.6) 
Minimum SBP-Induction Time   90.6  (21.3)   90.3  (20.7) 
Minimum SBP-Maintenance Time   94.8  (17.8)   83.8  (14.2) 
Minimum SBP- Awakening Time   123.8  (25.1)   117.6  (23.0) 
Maximum SBP-Induction Time   156.0  (26.9)   153.6  (29.6) 
Maximum SBP- Maintenance Time   157.8  (28.0)   144.6  (26.1) 
Maximum SBP-Awakening Time   156.6  (29.1)   153.4  (27.6) 

No statistical analysis provided for Systolic Blood Pressure (SBP)



9.  Secondary:   Vital Signs (SBP and DBP Changes)   [ Time Frame: From pre-induction to Postoperative Day 3 ]

Measure Type Secondary
Measure Title Vital Signs (SBP and DBP Changes)
Measure Description Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
Time Frame From pre-induction to Postoperative Day 3  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 292   294 
Vital Signs (SBP and DBP Changes) 
[Units: Mm Hg]
Mean (Standard Deviation)
   
SBP-Day 1   -12.2  (25.4)   -14.2  (26.8) 
SBP-Day 2   -10.8  (26.6)   -10.7  (25.6) 
SBP-Day 3   -11.9  (24.7)   -12.2  (25.0) 
DBP-Day 1   -6.05  (14.91)   -6.15  (15.10) 
DBP- Day 2   -3.32  (14.53)   -1.46  (13.41) 
DBP-Day 3   -3.73  (14.05)   -2.61  (13.90) 

No statistical analysis provided for Vital Signs (SBP and DBP Changes)



10.  Secondary:   Vital Signs (Heart Rate Changes)   [ Time Frame: From pre-induction to Postoperative Day 3 ]

Measure Type Secondary
Measure Title Vital Signs (Heart Rate Changes)
Measure Description Changes from baseline for Heart Rate (HR)
Time Frame From pre-induction to Postoperative Day 3  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
Sevoflurane 0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 292   294 
Vital Signs (Heart Rate Changes) 
[Units: Beats per minute]
Mean (Standard Deviation)
   
HR-Day 1   6.35  (12.03)   6.35  (12.91) 
HR-Day 2   8.81  (13.64)   9.85  (12.93) 
HR-Day 3   6.44  (11.72)   8.90  (14.14) 

No statistical analysis provided for Vital Signs (Heart Rate Changes)



11.  Secondary:   Number of Participants With Chest Pain During the 3 Postoperative Days   [ Time Frame: From Day 0 until Postoperative Day 3 ]

Measure Type Secondary
Measure Title Number of Participants With Chest Pain During the 3 Postoperative Days
Measure Description Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
Time Frame From Day 0 until Postoperative Day 3  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 292   294 
Number of Participants With Chest Pain During the 3 Postoperative Days 
[Units: Participants]
   
Day 0   0   0 
Day 1   0   2 
Day 2   1   2 
Day 3   2   3 

No statistical analysis provided for Number of Participants With Chest Pain During the 3 Postoperative Days



12.  Secondary:   Urine Output   [ Time Frame: From Day 0 until Postoperative Day 1 ]

Measure Type Secondary
Measure Title Urine Output
Measure Description Urine volume in milliliter (mL) during the first postoperative hours
Time Frame From Day 0 until Postoperative Day 1  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Measured Values
   Xenon   Sevoflurane 
Participants Analyzed 
[Units: Participants]
 292   294 
Urine Output 
[Units: mL]
Mean (Standard Deviation)
 1279.0  (723.1)   1324.4  (631.8) 

No statistical analysis provided for Urine Output




  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Adverse Events observed after the start of study drug administration and during postoperative 3-day period
Additional Description Participants at risks are the patients from the Treated Set, ie randomised patients who received the study medication.

Reporting Groups
  Description
Xenon 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
Sevoflurane 0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)

Serious Adverse Events
    Xenon   Sevoflurane
Total, Serious Adverse Events     
# participants affected / at risk   17/292 (5.82%)   17/294 (5.78%) 
Cardiac disorders     
Myocardial Infarction †     
# participants affected / at risk   3/292 (1.03%)   3/294 (1.02%) 
Cardio-respiratory arrest †     
# participants affected / at risk   0/292 (0.00%)   2/294 (0.68%) 
Acute Coronary Syndrome †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Acute Myocardial Infarction †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Arrhythmia supraventricular †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Atrial Fibrillation †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Bradyarrhythmia †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Subendocardial ischemia †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Hepatobiliary disorders     
Gallblader Necrosis †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Injury, poisoning and procedural complications     
Post Procedural Haemorrhage †     
# participants affected / at risk   2/292 (0.68%)   3/294 (1.02%) 
Post Procedural Haematoma †     
# participants affected / at risk   2/292 (0.68%)   2/294 (0.68%) 
Procedural Hypotension †     
# participants affected / at risk   1/292 (0.34%)   1/294 (0.34%) 
Graft thrombosis †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Operative Haemorrhage †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Shunt Trombosis †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Wound †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Investigations     
Troponin Increased †     
# participants affected / at risk   1/292 (0.34%)   2/294 (0.68%) 
Metabolism and nutrition disorders     
Diabetic Ketoacidosis †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Nervous system disorders     
Ischaemic Stroke †     
# participants affected / at risk   0/292 (0.00%)   2/294 (0.68%) 
Agitation †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Cerebrovascular Accident †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Confusional State †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Loss of Consciousness †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Transient Ischaemic Attack †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Psychiatric disorders     
Aggression †     
# participants affected / at risk   1/292 (0.34%)   0/294 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia †     
# participants affected / at risk   0/292 (0.00%)   3/294 (1.02%) 
Vascular disorders     
Peripheral Ischaemia †     
# participants affected / at risk   2/292 (0.68%)   1/294 (0.34%) 
Hypertension †     
# participants affected / at risk   0/292 (0.00%)   1/294 (0.34%) 
Events were collected by systematic assessment




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Yannick LE MANACH, MD, PhD
Organization: Population Health Research Institute - Mc Master University, Hamilton CANADA
phone: 0012892606840
e-mail: Yannick.Lemanach@phri.ca



Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01120405     History of Changes
Other Study ID Numbers: EudraCT #2010-018703-28
First Submitted: May 4, 2010
First Posted: May 11, 2010
Results First Submitted: March 20, 2014
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014