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Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra: A Randomized Controlled Trial


Phase 3
19 Years
85 Years
Not Enrolling
Female
Venous Thrombosis

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Trial Information

Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra: A Randomized Controlled Trial


To assess the effectiveness of Arixtra in the prophylaxis of deep venous thromboembolism in
gynecologic oncology patients undergoing abdominopelvic surgery.


Inclusion Criteria:



- All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.

- Patients must be competent to self-administer injections, or must have caregivers or
nurses who can perform injections

- Patients must have signed an approved informed consent

Exclusion Criteria:

- Patients with medical history which requires chronic anticoagulation (i.e. previous
DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)

- Patients with contraindications to anticoagulation (generalized bleeding disorders,
peptic ulcer disease, hemorrhagic stroke, etc)

- Contraindications to placement of ICDs (history of lower extremity venous stasis
ulcers)

- Patients receiving low molecular weight heparin or unfractionated heparin for
prophylaxis post-operatively

- Patients who are unable to receive injections as an outpatient and/or 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

- Hypersensitivity to low molecular weight heparin

- Patients who are pregnant or have a positive pregnancy test.

- Patients receiving continuous (indwelling) epidural.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Outcome Description:

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements.

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Warner K. Huh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F070727009

NCT ID:

NCT00539942

Start Date:

April 2007

Completion Date:

June 2010

Related Keywords:

  • Venous Thrombosis
  • Randomized Clinical Trials
  • Randomized Controlled Trial
  • Venous thrombosis
  • Anticoagulant Drugs
  • Doppler Ultrasound
  • Postoperative complications
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

Name

Location

UAB, Women's and Infant Center, 1700 6th Avenue SouthBirmingham, Alabama  35233