NCT03200613

Brief Summary

Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first. Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio). The primary efficacy endpoint will be a composite of symptomatic, objectively verified, venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

June 21, 2017

Last Update Submit

February 18, 2020

Conditions

Spinal Cord InjuriesVenous Thromboembolism

Keywords

Spinal cord injuryVenous thromboembolismHemorrhage

Outcome Measures

Primary Outcomes (1)

  • Primary feasibility outcome: recruitment rate per year (i.e. the screened to enrolled ratio)

    The investigators define success as the ability to identify 20 eligible patients at each center per 12-month period.

    24 months

Secondary Outcomes (2)

  • Composite of Symptomatic Venous Thromboembolism or Sudden Death Where Pulmonary Embolism Cannot be Excluded

    24 months

  • Major Bleeding

    24 months

Study Arms (2)

Apixaban

EXPERIMENTAL

Apixaban 2.5 mg orally twice daily

Drug: Apixaban

Low Molecular Weight Heparin

ACTIVE COMPARATOR

Either enoxaparin 40 mg or dalteparin 5000 units subcutaneously once daily

Drug: Low molecular weight heparin

Interventions

ApixabanDRUG

2.5 mg orally twice daily

Also known as: Eliquis
Apixaban
Low molecular weight heparinDRUG

Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily

Also known as: Lovenox or Fragmin
Low Molecular Weight Heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years old) with acute spinal cord injury (SCI) presenting to the hospital within 1 week of SCI and is at least 36 h after the injury
  • Traumatic SCI
  • SCI with or without other injuries

You may not qualify if:

  • Already on therapeutic oral anticoagulation prior to enrollment
  • Active bleeding, intracranial or perispinal hematoma, or acquired or congenital bleeding disorder
  • Pregnancy or breast feeding
  • Severe renal failure (creatinine clearance ≤30 ml/min)
  • Liver cirrhosis
  • Severe thrombocytopenia (platelets \<50)
  • Attending physician believes that the patient is not suitable for the study (for example, psychiatric disorder; history of non-compliance)
  • Geographic inaccessibility: planned transfer to other site where follow-up not possible
  • Failure to obtain written consent
  • Previous hypersensitivity reaction to study drugs
  • Patients with expected short hospital admission (≤7 days) due to minor injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

  • Piran S, Schulman S. Incidence and risk factors for venous thromboembolism in patients with acute spinal cord injury: A retrospective study. Thromb Res. 2016 Nov;147:97-101. doi: 10.1016/j.thromres.2016.09.030. Epub 2016 Oct 3.

    PMID: 27721141BACKGROUND

  • Piran S, Schulman S. Thromboprophylaxis in Patients with Acute Spinal Cord Injury: A Narrative Review. Semin Thromb Hemost. 2019 Mar;45(2):150-156. doi: 10.1055/s-0039-1678720. Epub 2019 Feb 11.

    PMID: 30743281BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesVenous ThromboembolismHemorrhage

Interventions

apixabanHeparin, Low-Molecular-WeightEnoxaparinDalteparin

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Open Label
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 27, 2017

Study Start

September 1, 2017

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)