What side effects are associated with this type of intervention?

MAP augmentation with vasopressors, used to increase blood pressure and improve spinal cord perfusion, can lead to side effects such as hypertension, arrhythmias, and potential end-organ damage due to increased blood pressure. VTE prophylaxis with anticoagulants, aimed at preventing blood clots, carries risks including bleeding complications, such as intracranial or intraspinal hemorrhage, and other bleeding events that may require medical intervention. Close monitoring is essential to minimize these risks.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments directly targeting spinal cord hemorrhage. However, vasopressors are commonly used to manage mean arterial pressure (MAP) in acute spinal cord injury to improve spinal cord perfusion, and anticoagulants are used for venous thromboembolism (VTE) prophylaxis to prevent blood clots. These treatments are part of broader critical care strategies rather than specific FDA-approved drugs for spinal cord hemorrhage.

What other types of research exist?

A promising novel alternative to MAP augmentation with vasopressors for spinal cord hemorrhage patients is spinal cord stimulation (SCS), which has been shown to improve blood flow and reverse vasoconstriction. However, no specific novel alternatives to VTE prophylaxis with anticoagulants were identified in the provided context.

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MRI Evaluation for Spinal Cord Injury (CHASM Trial)

N/A

Recruiting

Led By Brian Kwon, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute tSCI injury involving bony spinal levels between C0 and T1

Be older than 18 years old

Must not have

Spinal cord injury due to infection

Pathological fracture due to metabolic condition or neoplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up injury to 6 months post injury

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if raising blood pressure and preventing blood clots can help with bleeding in the spinal cord after an injury. It focuses on patients with a specific type of spinal injury and aims to manage blood flow and prevent clots to improve recovery. A medication is used to maintain higher blood pressure in patients with recent spinal cord injuries to support better outcomes.

Who is the study for?

This trial is for adults aged 19 or older who have suffered a traumatic spinal cord injury between the base of the skull and top of the chest (C0-T1) and are admitted to the study site within a day. They must be able to consent and have certain levels of impairment. Those with MRI-incompatible devices, very high BMI, incomplete assessments, injuries from infection or cancer, or multiple severe injuries can't join.

What is being tested?

The study uses MRI scans to see if treatments right after a spinal cord injury affect bleeding in the spine. It looks at two things: whether raising blood pressure with drugs (vasopressors) and preventing blood clots with anticoagulants influence hemorrhage during the first two weeks post-injury.

What are the potential side effects?

MRI itself doesn't usually cause side effects but lying still in a scanner might be uncomfortable for some people. The focus here is on observing changes rather than direct side effects from interventions like vasopressors or anticoagulants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My spinal injury is between the base of my skull and the top of my mid-back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My spinal cord injury was caused by an infection.

Select...

I have a broken bone caused by a disease or cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ injury to 6 months post injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~injury to 6 months post injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and injury to 6 months post injury for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemorrhage Quantification 1

Hemorrhage Quantification 2

Hemorrhage Quantification 3

+1 more

Secondary study objectives

Hemodynamic Management Assessment 1

Hemodynamic Management Assessment 2

Other study objectives

Neurologic Assessments

Side effects data

From 2023 Phase 4 trial • 69 Patients • NCT03973489

25%

Dry mouth

21%

Parasthesia

17%

Heart Palpitations

13%

Other

13%

Fatigue/Somnolence

Dizziness

Headache

Confusion/Memory Impairment

100%

80%

60%

40%

20%

Study treatment Arm

Methamphetamine

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic resonance imaging (MRI)

2019

Completed Phase 4

~1260

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal cord hemorrhage include MAP augmentation with vasopressors and VTE prophylaxis with anticoagulants. MAP augmentation with vasopressors works by increasing blood pressure, which improves spinal cord perfusion and helps to ensure that the injured spinal cord receives adequate oxygen and nutrients, potentially limiting further damage. VTE prophylaxis with anticoagulants prevents the formation of blood clots, which is crucial because patients with spinal cord injuries are at a higher risk for venous thromboembolism due to immobility. Preventing blood clots reduces the risk of additional complications, such as pulmonary embolism, which can be life-threatening. Together, these treatments aim to stabilize the patient's condition and prevent secondary injuries, improving overall outcomes.

Cerebral Hemorrhage Following Chiropractic Activator Treatment - Case Report and Review of Literature.The role of hemorrhage following spinal-cord injury.