A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis

NCT00789399 | Terminated Results DMC

• 1 other identifier: 00508826
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated and redo isolated) versus treatment with placebo. All consecutive patients scheduled for CABG surgery that meet the general inclusion and none of the exclusion criteria will be considered for enrollment in the study. Consecutive patients will be randomized on the day of admission prior to their CABG surgery into one of two groups. One group will be randomized to the placebo while the second group will receive 2.5 mg Fondaparinux Sodium injections. Both groups will receive routine mechanical prophylaxis as determined by the treating physicians. Group randomized to receive Fondaparinux Sodium will receive a 2.5 mg SQ daily drug dose starting 12 +/- 2 hours post-wound closure or the following day in the morning (at the discretion of the cardiothoracic surgeon). The second dose would be administered 24 hours later and the dosing will then be once a day. The group randomized to placebo will receive subcutaneous equivolume isotonic saline at the same time points described above. Patients randomized will receive a 2.5 mg dose of Fondaparinux Sodium or placebo subcutaneously for a total of 3-9 days post CABG with day 1 being the day of surgery. The drug will be discontinued if the patient is discharged before day 9. If the patient stays for more than 9 days inside hospital, a duplex would be obtained per protocol and further DVT prevention measures would be instituted per the discretion of treating physician. Patients will be assessed daily while hospitalized for any symptoms and adverse reactions and will undergo laboratory testing (CBC, PT/INR, PTT and UA) as specified in the protocol. Post-op day 3-9(no later than 2 days after the last preventive drug dose) patients will undergo the protocol specific lower limb venous duplex scan and earlier if symptomatic. Patients will also be contacted (phone/office visit) for follow-up 25-35 days post CABG to assess for signs or symptoms of deep venous thrombosis or thromboembolism and for any potential complications.

Conditions

Deep Vein Thrombosis; Coronary Artery Bypass Surgery; Venous Thromboembolism

Keywords

deep vein thrombosis; coronary artery bypass surgery; Venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11

  there were 2 events; one in placebo group and one in fondaparinux group

  11 days

Secondary Outcomes (1)

• Number of Participants With a Venous Thromboembolisms to 35 Days

  35 days

Study Arms (2)

Fondaparinux

ACTIVE COMPARATOR

Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG

Drug: Fondaparinux

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Fondaparinux DRUG

Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG

Also known as: DVT, CABG

Fondaparinux

Placebo OTHER

subcutaneous equivolume isotonic saline

Also known as: DVT, CABG

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients undergoing isolated or redo isolated CABG
• Patients must provide written informed consent
• Patients must agree to comply with study procedures for the entire length of the study.
• Must be 18 years old or greater.

You may not qualify if:

• Patients with medical history that requires chronic anticoagulation with unfractionated heparin or coumadin or LMWH or heparinoids (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)
• Patients with contraindications to anticoagulation (coagulopathy e.g, INR\>/=1.5, generalized bleeding disorders, peptic ulcer disease, hemorrhagic or ischemic stroke, etc within last 3 months)
• Patients who are unable to undergo a doppler ultrasound of the lower extremities
• Renal insufficiency (creatinine clearance \< 30 mL/min)
• Patients who have a body weight \< 50 kg
• Patients receiving continuous (indwelling) epidural
• Physician diagnosed acute or chronic hepatic failure
• Pregnancy
• Patients with life expectancy \< 6 months
• Platelet count below 100,000/ mm-3
• History of documented VTE within last 3 months.
• Acute bacterial endocarditis
• Cerebral metastasis or abscess
• Inability to consent
• Refusal by treating physician

Sponsors & Collaborators

• Prairie Education and Research Cooperative: lead
• American College of Phlebology: collaborator

Related Publications (1)

• Kolluri R, Plessa AL, Sanders MC, Singh NK, Lucore C. A randomized study of the safety and efficacy of fondaparinux versus placebo in the prevention of venous thromboembolism after coronary artery bypass graft surgery. Am Heart J. 2016 Jan;171(1):1-6. doi: 10.1016/j.ahj.2015.10.013. Epub 2015 Oct 21.

  PMID: 26699594 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Prairie Education and Research Cooperative

jchambers@prairieresearch.com

217 492 9104

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 11, 2008
• Study Start: November 19, 2009
• Primary Completion: September 21, 2013
• Study Completion: September 21, 2013
• Last Updated: September 8, 2022
• Results First Posted: September 8, 2022

Record last verified: 2022-08