Trial Outcomes & Findings for Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (NCT NCT02712788)

Last Updated: 2019-07-02

Results Overview

Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. The Modified Rankin scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

6 months

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Milrinone Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
Overall Study STARTED	2	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Milrinone Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Population: The 2 subjects in the milrinone arm were unable to be analyzed. 1 subject was withdrawn due to ineligibilty and the other was withdrawn per physician discretion.

Outcome measures

Outcome measures
Measure	Milrinone Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo n=2 Participants Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
Modified Rankin Scale (mRS) at 6 Months	—	1.5 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 12 months

Population: The 2 subjects in the milrinone arm were unable to be analyzed. 1 was withdrawn due to ineligibility and the other was withdrawn due to physician discretion.

Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. THe Modified Rankin Scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Milrinone Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo n=2 Participants Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
mRS at 12 Months	—	2 score on a scale Interval 1.0 to 3.0

Adverse Events

Milrinone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Milrinone n=2 participants at risk Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo n=2 participants at risk Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
Cardiac disorders Hypotension	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Vascular disorders Gastroduodenal Artery Bleed	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug	0.00% 0/2 • 30 days following discontinuation of study drug
Vascular disorders Thalamic and basal ganglia infarcts	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug

Other adverse events

Other adverse events
Measure	Milrinone n=2 participants at risk Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo n=2 participants at risk Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo
Renal and urinary disorders Urinary Tract Infection	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug	0.00% 0/2 • 30 days following discontinuation of study drug
Nervous system disorders Fever (neurogenic)	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Vascular disorders epistaxis	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Vascular disorders Acute Deep Venous Thrombosis	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Gastrointestinal disorders Hematochezia	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug
Skin and subcutaneous tissue disorders Incontinence associated dermatitis	0.00% 0/2 • 30 days following discontinuation of study drug	50.0% 1/2 • Number of events 1 • 30 days following discontinuation of study drug

Additional Information

Heather Cero, RN - research cooordinator

Indiana University

Phone: 317-396-1398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Milrinone n=2 Participants Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Milrinone	Placebo n=2 Participants Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol. Placebo	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants