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Randomized Controlled Trial
. 2025 Sep 2;8(9):e2525364.
doi: 10.1001/jamanetworkopen.2025.25364.

Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial

Ruba Sajdeya  1 , N David Yanez  2 , Michael Kampp  3 , Michael D Goodman  4 , David Zonies  5 , Brandon Togioka  5 , Andrew Nunn  6 , Robert D Winfield  7 , Niels D Martin  8 , Anirudh Kohli  9 , Toan T Huynh  10 , David O Okonkwo  11 , Roy A Poblete  12 , Emily J Gilmore  3 , Randall M Chesnut  13 , Aaron E Bunnell  13 , Tetsu Ohnuma  1 , Mona Hashemaghaie  1 , Miriam M Treggiari  1
Affiliations
Randomized Controlled Trial

Early Blood Pressure Targets in Acute Spinal Cord Injury: A Randomized Clinical Trial

Ruba Sajdeya et al. JAMA Netw Open. .

Abstract

Importance: Early blood pressure management is central to neurologic resuscitation of spinal cord injury; however, the role of augmented blood pressure is unclear.

Objective: To compare the efficacy and safety of augmented vs conventional blood pressure on 6-month neurologic outcomes after acute spinal cord injury.

Design, setting, and participants: This multicenter randomized clinical trial took place from October 3, 2017, to July 26, 2023, and assessed patients 18 years or older with spinal cord injury followed up for 6 months at 13 large US trauma centers.

Interventions: Patients were equally randomized to augmented (>85-90 mm Hg) or conventional (>65-70 mm Hg) mean arterial pressure for 7 days or until intensive care unit discharge.

Main outcomes and measures: Primary end points were change in motor and sensory American Spinal Injury Association Impairment Scale scores from baseline to 6 months. Safety end points included organ dysfunction and complications.

Results: The trial randomized 92 patients (mean [SD] age, 53.78 [18.74] years; 76 [83%] male). At 6 months, 38 patients had completed follow-up and 15 had died. Among survivors, there were no mean (SD) differences in change from baseline in upper extremity motor scores (34.95 [3.25] vs 32.95 [3.65]; difference, 2.48; 95% CI, -5.93 to 10.90; P = .55), lower extremity motor scores (18.53 [4.62] vs 19.95 [4.59]; difference, -4.56; 95% CI, -16.11 to 7.03; P = .43), or total sensory scores (108.47 [12.49] vs 130.89 [14.87]; difference, -32.00; 95% CI, -65.40 to 1.40; P = .06) comparing the augmented and conventional groups. The augmented group had higher mean (SD) modified Sequential Organ Failure Assessment scores (excluding cardiovascular components) at day 3 (1.65 [1.79] vs 0.80 [1.10]; difference, 0.85; 95% CI, 0.23-1.47; P = .008) and day 6 (1.55 [1.82] vs 0.80 [1.35]; difference, 0.74; 95% CI, 0.05-1.44; P = .04), longer mechanical ventilatory support (9.44 [15.27] vs 3.78 [8.42] days; difference, 5.67 days; 95% CI, 0.48-10.85 days; P = .03), and more respiratory complications (36 [78%] vs 18 [39%]; risk difference, 40%; 95% CI, 22%-58%; P < .001) than the conventional group. No differences in mortality or other secondary outcomes were observed.

Conclusions: Although underpowered, this randomized clinical trial of patients with spinal cord injury did not demonstrate better neurologic recovery comparing early augmented and conventional blood pressure and calls this practice into question. Further study is needed to identify groups who may benefit from augmenting blood pressure and determine potential harm mechanisms.

Trial registration: ClinicalTrials.gov Identifier: NCT02878850.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Winfield reported receiving grants from Army Medical Research during the conduct of the study and personal fees from Haemonetics Corp and grants from the Centers for Disease Control and Prevention and CSL Behring outside the submitted work. Dr Okonkwo reported receiving royalties from NuVasive and Highridge outside the submitted work. Dr Bunnell reported receiving grants from University of Washington during the conduct of the study. Dr Treggiari reported receiving grants from the National Institutes of Health and Edwards Life Sciences Corporation outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Chart
Of the 7 patients who died before 6 months in the conventional blood pressure (CBP) group, 2 had missing baseline American Spinal Injury Association (ASIA) scores and were excluded from the sensitivity analysis. CHF indicates congestive heart failure; CV, cardiovascular; GCS, Glasgow Coma Scale; NYHA, New York Heart Association.
Figure 2.
Figure 2.. Mean Arterial Pressure (MAP) During the 7-Day Study Period
Sample sizes represent the number of patients with MAP monitoring data in the numerator and the total number of patients studied daily in each blood pressure control group. Daily MAP values are the mean of MAP recordings every 4 hours in the intensive care unit or acute care setting from screening (before initiating study protocols) until study day 7 or intensive care unit discharge. MAP values were significantly lower in the conventional blood pressure (CBP) group (>65-70 mm Hg) than the augmented blood pressure (ABP) group (>85-90 mm Hg) during the 7 protocol-specified days (P < .001 by repeated-measures regression analysis), noting that the target MAPs were set as lower limit targets that the achieved MAP values were allowed to exceed. The whiskers represent 95% CIs.
Figure 3.
Figure 3.. Changes in American Spinal Injury Association (ASIA) Impairment Scale (AIS) Grade at 6 Months
ABP indicates augmented blood pressure; CBP, conventional blood pressure.
See this image and copyright information in PMC

References

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