NCT00894283

Brief Summary

This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2009

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

May 5, 2009

Last Update Submit

June 5, 2019

Conditions

Deep Venous ThrombosisPulmonary Embolism

Keywords

DVTPEMRVbariatric surgery

Outcome Measures

Primary Outcomes (1)

  • To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.

    2 years

Secondary Outcomes (1)

  • To assess the relationship of Anti-factor Xa levels and the occurrence of deep venous thrombosis and pulmonary emboli in bariatric patients receiving standard dose of anticoagulation (enoxaparin/Lovenox or fondaparinux/Arixtra).

    2 years

Study Arms (2)

Enoxaparin

ACTIVE COMPARATOR

Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.

Drug: Enoxaparin

Fondaparinux

ACTIVE COMPARATOR

Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.

Drug: Fondaparinux

Interventions

EnoxaparinDRUG

Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.

Enoxaparin
FondaparinuxDRUG

Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.

Fondaparinux

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women 18 years or older.
  • Body mass index (BMI) of 35kg/m2 or greater.
  • Undergoing laparoscopic bariatric surgery, i.e., laparoscopic sleeve gastrectomy, laparoscopic Roux-en Y gastric bypass or laparoscopic duodenal switch.

You may not qualify if:

  • History of previous deep vein thrombosis.
  • History of previous pulmonary emboli.
  • History of documented clotting/coagulation disorder.
  • History of cancer.
  • Weight \< 50 kg or \> 200 kg or unable to fit in MRI scanner.
  • Presence of metallic foreign bodies
  • Recent history of smoking (within the last year).
  • History of venous stasis disease.
  • History of obesity hypoventilation syndrome.
  • Patients who are unable to lay flat for extended periods of time or are claustrophobic.
  • Patients who have a pacemaker, an implanted defibrillator or certain other implanted or electronic or metallic devices (implanted medical or metallic devices, shrapnel, or metal).
  • History of hypersensitivity reaction to anticoagulation products.
  • History of HIT (Heparin Induced Thrombocytopenia.
  • History of Renal Insufficiency (Creatinine Clearance \< 50).
  • Active clinically significant bleeding.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.

    PMID: 36413425DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

EnoxaparinFondaparinux

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesOligosaccharides

Study Officials

  • Kimberley E Steele, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 6, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

US(1)