Trial Outcomes & Findings for Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury (NCT NCT02878850)

Results Overview

Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

6 months after spinal cord injury

Results posted on

2026-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Augmented Blood Pressure Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure Subjects will have their blood pressure kept in a normal range.
Overall Study STARTED	46	46
Overall Study COMPLETED	30	35
Overall Study NOT COMPLETED	16	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A complete neurological exam could not be obtained in 3 patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Blood Pressure n=46 Participants Subjects will have their blood pressure kept in a normal range.	Total n=92 Participants Total of all reporting groups	Augmented Blood Pressure n=46 Participants Subjects will have their blood pressure kept in a higher range.
Age, Continuous	54.0 years STANDARD_DEVIATION 17.9 • n=46 Participants	53.8 years STANDARD_DEVIATION 17.7 • n=92 Participants	53.6 years STANDARD_DEVIATION 17.8 • n=46 Participants
Sex: Female, Male Female	8 Participants n=46 Participants	16 Participants n=92 Participants	8 Participants n=46 Participants
Sex: Female, Male Male	38 Participants n=46 Participants	76 Participants n=92 Participants	38 Participants n=46 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=46 Participants	12 Participants n=92 Participants	7 Participants n=46 Participants
Baseline American Spinal Injury Association (ASIA) Score Upper Extremities Motor Score	23.0 Score STANDARD_DEVIATION 17.8 • n=43 Participants • A complete neurological exam could not be obtained in 3 patients	19.2 Score STANDARD_DEVIATION 15.9 • n=89 Participants • A complete neurological exam could not be obtained in 3 patients	17.1 Score STANDARD_DEVIATION 13.4 • n=46 Participants • A complete neurological exam could not be obtained in 3 patients
Baseline American Spinal Injury Association (ASIA) Score Lower Extremities Motor Score	6.1 Score STANDARD_DEVIATION 12.2 • n=43 Participants • A complete neurological exam could not be obtained in 3 patients	6.5 Score STANDARD_DEVIATION 12.8 • n=89 Participants • A complete neurological exam could not be obtained in 3 patients	6.9 Score STANDARD_DEVIATION 13.6 • n=46 Participants • A complete neurological exam could not be obtained in 3 patients
Baseline American Spinal Injury Association (ASIA) Score Total Sensory Score	77.3 Score STANDARD_DEVIATION 44.2 • n=43 Participants • A complete neurological exam could not be obtained in 3 patients	82.7 Score STANDARD_DEVIATION 49.7 • n=89 Participants • A complete neurological exam could not be obtained in 3 patients	87.8 Score STANDARD_DEVIATION 54.4 • n=46 Participants • A complete neurological exam could not be obtained in 3 patients

PRIMARY outcome

Timeframe: 6 months after spinal cord injury

Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up

Change from baseline in ASIA Upper Extremities Motor Score (UEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The UEMS score ranges from 0 to 50, with 50 indicating no deficits.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a normal range.
Change From Baseline in American Spinal Injury (ASIA) Upper Extremities Motor Score	15.58 Scores on a scale Standard Deviation 16.23	12.63 Scores on a scale Standard Deviation 13.42

PRIMARY outcome

Timeframe: 6 months after spinal cord injury

Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up

Change from baseline in ASIA Lower Extremities Motor Score (LEMS), comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The LEMS score ranges from 0 to 50, with 50 indicating no deficits.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a normal range.
Change From Baseline in American Spinal Injury (ASIA) Lower Extremities Motor Score	10.79 Scores on a scale Standard Deviation 16.66	16.16 Scores on a scale Standard Deviation 18.16

PRIMARY outcome

Timeframe: 6 months after spinal cord injury

Population: ABP: 46 patients allocated to intervention, 8 died, 3 unable to complete physical exam, 16 lost to follow up CBP: 46 patients allocated to intervention, 7 died, 9 unable to complete physical exam, 11 lost to follow up

Change from baseline in ASIA Sensory Score, comparing patients maintained at a MAP target between 65 and 70 mm Hg, and patients maintained at a MAP target between 85 and 90 mm Hg for a duration of seven days or until ICU discharge. The total Sensory Score adds light touch points (max 112) and pin prick points (max 112). The total score ranges from 0 to 224, with higher scores indicating better neurological outcomes.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a normal range.
Change From Baseline in American Spinal Injury Association (ASIA) Sensory Score	6.26 Scores on a scale Standard Deviation 41.32	41.63 Scores on a scale Standard Deviation 58.97

SECONDARY outcome

Timeframe: 6 months after spinal cord injury

Spinal Cord Independence Measure III (SCIM III). The total SCIM III Score ranges from 0 to 100 points, with 0 indicating complete dependence and 100 indicating complete independence.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=22 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=26 Participants Subjects will have their blood pressure kept in a normal range.
Spinal Cord Independence Measure III Score	27.48 Scores on a scale Standard Deviation 19.43	28.11 Scores on a scale Standard Deviation 20.82

SECONDARY outcome

Timeframe: 6 months after spinal cord injury

Pain Interference with daily activity on the International Spinal Cord Injury Basic Pain Data Set. Pain Interference Score ranges from 0 to 10, with higher scores indicating higher pain levels.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=22 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=26 Participants Subjects will have their blood pressure kept in a normal range.
Pain Scores on the International Spinal Cord Injury Basic Pain Data Set	5.21 Scores on a scale Standard Deviation 3.17	4.86 Scores on a scale Standard Deviation 3.66

SECONDARY outcome

Timeframe: 6 months after spinal cord injury

The ISCIQoL Basic Data Set is a 3-item self-report tool of quality of life across three domains: 1. Satisfaction with life as a whole; 2. Satisfaction with physical health; 3. Satisfaction with psychological health. Each domain scores from 0 to 10, and the total score range (sum of the 3 domains) ranges from 0 to 30. Higher scores indicate better perceived quality of life.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=22 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=26 Participants Subjects will have their blood pressure kept in a normal range.
International Spinal Cord Injury Quality of Life (ISCIQoL) Basic Data Set	19.94 Scores on a scale Standard Deviation 6.43	18.00 Scores on a scale Standard Deviation 7.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days after randomization or ICU discharge, whichever came first, assessed up to 7 days

Incidence of respiratory complications

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=45 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=45 Participants Subjects will have their blood pressure kept in a normal range.
Incidence of Respiratory Complications	36 Participants	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after spinal cord injury

Hypotension, hypertension, autonomic dysreflexia, edema, pulmonary embolism, deep venous thrombosis, other cardiovascular condition.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=19 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=24 Participants Subjects will have their blood pressure kept in a normal range.
Cardiovascular Function	6 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days after randomization

Modified Sequential Multiple Organ Assessment (SOFA) score on Day 7 after randomization. The modified SOFA score does not include the points contributed by the Cardiovascular system. The modified SOFA score ranges from 0 to 20, with higher scores indicating greater organ dysfunction and higher mortality risk.

Outcome measures

Outcome measures
Measure	Augmented Blood Pressure n=43 Participants Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=40 Participants Subjects will have their blood pressure kept in a normal range.
Sequential Multiple Organ Assessment (SOFA) Score	1.40 Scores on a scale Standard Deviation 1.84	0.78 Scores on a scale Standard Deviation 1.33

Adverse Events

Augmented Blood Pressure

Serious events: 12 serious events

Other events: 0 other events

Deaths: 8 deaths

Conventional Blood Pressure

Serious events: 13 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Augmented Blood Pressure n=46 participants at risk Subjects will have their blood pressure kept in a higher range.	Conventional Blood Pressure n=46 participants at risk Subjects will have their blood pressure kept in a normal range.
Cardiac disorders Cardiac Arrest	6.5% 3/46 • Number of events 3 • From enrollment up to 6 months	10.9% 5/46 • Number of events 5 • From enrollment up to 6 months
Respiratory, thoracic and mediastinal disorders Respiratory Complications	17.4% 8/46 • Number of events 8 • From enrollment up to 6 months	10.9% 5/46 • Number of events 5 • From enrollment up to 6 months
Infections and infestations Sepsis/Infection	10.9% 5/46 • Number of events 5 • From enrollment up to 6 months	10.9% 5/46 • Number of events 5 • From enrollment up to 6 months

Other adverse events

Adverse event data not reported

Additional Information

Miriam Treggiari

Duke University

Phone: 9196819933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place