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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American College of Phlebology
Information provided by (Responsible Party):
Raghu Kolluri, MD, Prairie Education and Research Cooperative
ClinicalTrials.gov Identifier:
NCT00789399
First received: November 7, 2008
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Deep Vein Thrombosis
Coronary Artery Bypass Surgery
Venous Thromboembolism
Drug: Fondaparinux
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Prairie Education and Research Cooperative:

Primary Outcome Measures:
  • Rate of asymptomatic proximal DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Asymptomatic Distal DVT [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 630
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fondaparinux
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Drug: Fondaparinux
Patients will receive a 2.5 mg dose of Fondaparinux subcutaneously for a total of 7 days post CABG
Other Names:
  • DVT
  • CABG
Placebo Comparator: Placebo Other: Placebo
subcutaneous equivolume isotonic saline
Other Names:
  • DVT
  • CABG

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion Criteria In order to be enrolled in the study, subjects must meet all of the inclusion criteria as listed below.

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

Subject Exclusion Criteria Any subject that meets any of the exclusion criteria listed below at baseline will be excluded from study participation.

  1. 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)
  2. 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)
  3. Patients who are unable to undergo a doppler ultrasound of the lower extremities
  4. Renal insufficiency (creatinine clearance < 30 mL/min)
  5. Patients who have a body weight < 50 kg
  6. Patients receiving continuous (indwelling) epidural
  7. Physician diagnosed acute or chronic hepatic failure
  8. Pregnancy
  9. Patients with life expectancy < 6 months
  10. Platelet count below 100,000/ mm-3
  11. History of documented VTE within last 3 months.
  12. Acute bacterial endocarditis
  13. Cerebral metastasis or abscess
  14. Inability to consent
  15. Refusal by treating physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789399

Locations
United States, Illinois
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Prairie Education and Research Cooperative
American College of Phlebology
Investigators
Principal Investigator: Raghu Kolluri, MD Prairie Edcuation and Research Cooperative
  More Information

No publications provided

Responsible Party: Raghu Kolluri, MD, Prairie Education and Research Cooperative
ClinicalTrials.gov Identifier: NCT00789399     History of Changes
Other Study ID Numbers: 00508826
Study First Received: November 7, 2008
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Prairie Education and Research Cooperative:
deep vein thrombosis
coronary artery bypass surgery
Venous thromboembolism

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014