ClinicalTrials.gg
RecruitingNCT05484557Updated Sep 9, 2026

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

An interventional study of Apixaban and Enoxaparin Sodium in Spinal Cord Injuries and Spinal Diseases, sponsored by Loewenstein Hospital. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Loewenstein Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively).

Endpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

02

Conditions studied

  • Spinal Cord Injuries
  • Spinal Diseases
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 60 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Loewenstein Hospital is the lead sponsor of 25 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • spinal cord injury (traumatic of not traumatic), Hebrew speaker.

Exclusion criteria

Exclusion Criteria:

  • for anticoagulant treatment
  • concomitant treatment with any other anticoagulant
  • anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury
  • active bleeding
  • any lesion or condition considered a significant risk factor for major bleeding.
  • hepatic disease associated with coagulopathy and clinically relevant bleeding risk
  • pregnancy or breast-feeding
  • heart valve related issues
  • galactose intolerance
  • active cancer
  • patients who require thrombolysis or pulmonary embolectomy
  • patients with renal impairment
  • sensitivity to of the medication
  • anti phospholipid syndrome
  • prosthetic heart valve
  • acute ischemic stroke
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    study

    treatment with Apixaban

    Drug: Apixaban

  • Active comparator
    Control

    treatment with Enoxaparin

    Drug: Enoxaparin Sodium

Interventions

06

What researchers measure

Primary outcomes

  1. Number of participants with venous thromboembolism (VTE)

    deep vein thrombosis or pulmonary embolism

    Time frame: 2 years

Secondary outcomes

  1. Number of participants with bleeding events.

    bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.

    Time frame: 6 to 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Aug 2027, 47 months after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 47 months is above that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2022
First posted
Aug 2, 2022
StartActual
Sep 6, 2023
Primary completionEst.
Aug 2027
CompletionEst.
Feb 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05484557
Lead sponsor
Loewenstein Hospital
Responsible party
amiram-catz (Head of the spinal department, Loewenstein Hospital) — Principal investigator
First posted
Aug 2, 2022
Start date
Sep 6, 2023
Primary completion
Aug 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Amiram Catz, MD PhD
Contact
amiramc@clalit.org.il
972-9-770-9934

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Apixaban

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