NCT00493896

Brief Summary

This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Typical duration for phase_3

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 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2.8 years

First QC Date

June 27, 2007

Last Update Submit

April 7, 2022

Conditions

Venous Thromboembolism

Keywords

Venous Thromboembolism ProphylaxisVTE prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Bleeding events

    inpatient hospitalization

Secondary Outcomes (1)

  • Development of thrombocytopenia

    inpatient hospitalization

Study Arms (2)

Fondaparinux

EXPERIMENTAL

Fondaparinux treatment - one standard of care option

Drug: Fondaparinux

2

ACTIVE COMPARATOR

Enoxaparin

Drug: Enoxaparin

Interventions

FondaparinuxDRUG

The dose for Arixtra is 2.5 mg once daily, subcutaneously.

Also known as: Arixtra
Fondaparinux
EnoxaparinDRUG

The dose for Lovenox is 40 mg once daily, subcutaneously.

Also known as: Lovenox
2

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability or legally authorized representative (LAR) to provide informed consent
  • Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.

You may not qualify if:

  • Active or suspected bleeding
  • Platelet count less than 100,000 per microliter (mm3) of blood
  • Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
  • Initial estimated CLcr \< 30 ml/min as determined by the Cockcroft-Gault equation
  • Initial labs indicative or suggestive of rapidly rising serum Creatinine (\>1 mg/dL/day)
  • Pregnancy (for medicolegal considerations)
  • Patients with or expecting to require an epidural catheter
  • Patients who are expected to have an immediate (within 24h) need for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

FondaparinuxEnoxaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydratesHeparin, Low-Molecular-WeightHeparinGlycosaminoglycans

Study Officials

  • Charles W Callender, MD

    Eastern VA Medical School, Norfolk, VA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 11, 2022

Record last verified: 2022-04