NCT02493543

Brief Summary

The purpose of this study is to determine the autoantibody profiles after spinal cord injury and their role in spontaneous functional recovery.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

3.5 years

First QC Date

July 7, 2015

Last Update Submit

February 22, 2018

Conditions

Spinal Cord Injuries

Keywords

autoantibodies

Outcome Measures

Primary Outcomes (1)

  • Changes in ASIA scores

    4 months

Secondary Outcomes (2)

  • Change in neurological level of injury

    4 months

  • Change in ASIA impairment scale (AIS)

    4 months

Other Outcomes (1)

  • Spinal cord independence measure (SCIM)

    Until discharge from the hospital (6-12 months)

Study Arms (2)

Spinal cord injury

Patients (n=90) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed twice: after recruitment and 3 months later.

Other: Blood collection

Controls

Control subjects (n=20) will undergo a common arm blood collection to determine autoantibody profiles in serum. This procedure will be performed only once.

Other: Blood collection

Interventions

Blood collectionOTHER

Blood collection from the subject's arm

ControlsSpinal cord injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute spinal cord injury admitted to the Spanish National Hospital for Paraplegics

You may qualify if:

  • Traumatic or non-progressive vascular SCI
  • Less than 45 days after lesion
  • Any neurological level
  • Complete and incomplete lesions
  • If patient has been treated with glucocorticoids, it should have passed at least 7 days from the end of the treatment

You may not qualify if:

  • Cauda equina syndrome
  • Autoimmune disorder
  • Tumor (even if benign)
  • Neurodegenerative disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Berufsgenossenschaftliche Unfallklinik Murnau

Murnau am Staffelsee, Germany

Location

Hospital Nacional de Parapléjicos, SESCAM

Toledo, Spain

Location

Related Publications (1)

  • Leister I, Altendorfer B, Maier D, Mach O, Wutte C, Grillhosl A, Arevalo-Martin A, Garcia-Ovejero D, Aigner L, Grassner L. Trajectory of Serum Levels of Glial Fibrillary Acidic Protein Within Four Weeks Post-Injury Is Related to Neurological Recovery During the Transition from Acute to Chronic Spinal Cord Injury. J Neurotrauma. 2023 May;40(9-10):999-1006. doi: 10.1089/neu.2022.0326. Epub 2022 Dec 9.

    PMID: 36200629DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Angel Arevalo-Martin, PhD

    Hospital Nacional de Parapléjicos, SESCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 9, 2015

Study Start

October 17, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

DE(1)ES(1)