Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— TEMPLE  

Official title:

Randomized Trial of Early Hemodynamic Management of Patients Following Acute Spinal Cord Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02878850
• Other study ID #: TEMPLE - 001
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: August 27, 2024

Study information

• Verified date: December 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about how participants heal from acute spinal cord injury.

Description:

In this study, the investigators will learn about the effect of targeted blood pressure management (TPM) on participants healing from acute spinal cord injury. The investigators want to learn: The effect of two types of TPM on long term motor and sensory outcomes. The effect of two types of TPM on long-term pain and functional independence outcomes. How safe TPM is for participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: August 27, 2024
• Est. primary completion date: August 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute traumatic spinal cord injury (SCI) involving neurological levels as defined by the ASIA neurological examination between C0 and T8 (tetraplegia) and resulting in new onset neurological deficits consistent with an ASIA motor assessment of level A, B or C.

2. Subject is 18 years of age or older.

Exclusion Criteria:

1. Penetrating SCI injury.

2. Isolated cauda equina syndrome or injury at bony level Th9 or below.

3. Pre-existing motor deficit secondary to chronic myelopathy.

4. History of demyelinating disease or central nervous system autoimmune disorder.

5. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D).

6. Acute, evolving or recent (30 days) myocardial infarction.

7. Chronic renal failure requiring dialysis.

8. Suspected or confirmed pregnancy.

9. Severe terminal disease with life expectancy less than 6 months.

10. Severe traumatic brain injury at presentation (GCS =8) with confirmation of injury on brain imaging.

11. A condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation.

12. Non-English or Non-Spanish Speaking.

13. Refusal of consent.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Other:
• Augmented Blood Pressure
Subjects will have their blood pressure kept in a higher range.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Atrium Health F.H. Sammy Ross Trauma Center	Charlotte	North Carolina
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Southern California	Los Angeles	California
United States	Yale University	New Haven	Connecticut
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of respiratory complications	Number of respiratory complications (Event frequency)	7 days after randomization or ICU discharge
Other	Number of cardiac complications	Number of cardiac complications (Event frequency)	7 days after randomization or ICU discharge
Other	Sequential Multiple Organ Failure score (SOFA)	Sequential Multiple Organ Failure score (SOFA) (Total Score, no units)	7 days after randomization or ICU discharge
Primary	Change from baseline in motor and sensory American Spinal Injury Association (ASIA) scores.	Change from baseline in long-term motor and sensory scores, 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.	6 months after spinal cord injury
Secondary	Spinal Cord Independence Measure III score	Spinal Cord Independence Measure III (Total Score, no units)	6 months after spinal cord injury
Secondary	Pain scores on the International Spinal Cord Injury Basic Pain Data Set	Pain scores on the International Spinal Cord Injury Basic Pain Data Set (Pain Interference Score; range 0-10)	6 months after spinal cord injury
Secondary	Quality of Life	Quality of Life (Life Satisfaction Score; range 0-10)	6 months after spinal cord injury
Secondary	Cardiovascular Function	Cardiovascular Function (Event occurrence)	6 months after spinal cord injury