Trial Outcomes & Findings for Intra-arterial Magnesium Administration for Acute Stroke (NCT NCT01502761)
NCT ID: NCT01502761
Last Updated: 2017-08-28
Results Overview
Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Results posted on
2017-08-28
Participant Flow
Participant milestones
| Measure |
Regional Intra-arterial Magnesium 0.75g
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intra-arterial Magnesium Administration for Acute Stroke
Baseline characteristics by cohort
| Measure |
Regional Intra-arterial Magnesium 0.75g
n=4 Participants
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.25 years
STANDARD_DEVIATION 13.25 • n=5 Participants
|
—
|
—
|
—
|
68.25 years
STANDARD_DEVIATION 13.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retrieverPopulation: Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns
Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.
Outcome measures
| Measure |
Regional Intra-arterial Magnesium 0.75g
n=4 Participants
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
|---|---|---|---|---|
|
Magnesium Concentration in Region of Cerebral Ischemia
Distal Mg level
|
1.475 meq/L
Standard Deviation .3403
|
—
|
—
|
—
|
|
Magnesium Concentration in Region of Cerebral Ischemia
Peripheral Mg level
|
1.513 meq/L
Standard Deviation .2462
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: intraprocedure, postoperative day 1, 1 month, 3 monthPeriprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)
Outcome measures
| Measure |
Regional Intra-arterial Magnesium 0.75g
n=4 Participants
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
|---|---|---|---|---|
|
Number of Participants With Procedure Related Serious Adverse Event
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Regional Intra-arterial Magnesium 0.75g
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Regional Intra-arterial Magnesium 1.5g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regional/ Distal (75/25%) Magnesium 1.5g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regional/ Distal (50/50%) Magnesium 1.5g
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regional Intra-arterial Magnesium 0.75g
n=4 participants at risk
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Blood and lymphatic system disorders
Parotiditis with sepsis
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
Other adverse events
| Measure |
Regional Intra-arterial Magnesium 0.75g
n=4 participants at risk
Regional only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional Intra-arterial Magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal(75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
Magnesium Sulfate: Intra-arterial
|
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
Magnesium Sulfate: Intra-arterial
|
|---|---|---|---|---|
|
Nervous system disorders
Cerebral Edema
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Nervous system disorders
Ischemic change on brain imaging
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Nervous system disorders
Hemorrhagic Transformation of stroke
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Cardiac disorders
Sick Sinus Syndrome
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Endocrine disorders
increased blood glucose
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
|
Renal and urinary disorders
Urinary Tract Infection
|
25.0%
1/4 • Number of events 1 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
—
0/0 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place