Institutional Review Board, Hospital for Special Surgery
May 02, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This research is being done to compare ‘calf squeezers’ (ActiveCare™ CECT) in combination with 81mg of Aspirin, with a medicine Lovenox to prevent blood clots after total hip replacement surgery.
Some patients who have hip replacement surgery get blood clots in their legs after surgery. Most doctors, including Dr. Padgett, give their patients medicine after surgery to help prevent blood clots. Another way to prevent blood clots is for the patient to wear a special kind of stocking or cuff around his/her legs which squeezes the legs. This helps move the blood back up the legs to the heart. In the past these cuffs, called ‘calf squeezers,’ were uncomfortable. Patients sometimes didn’t wear them, so doctors didn’t usually rely on the cuffs alone to prevent clots. A new kind of ‘calf squeezer’ (ActiveCare CECT), which is small and battery operated, is now available and may be more comfortable than the old kind of ‘calf squeezer.’
You have been asked to be in this study because you are having a hip replacement and are at a risk of having a blood clot.
The investigators hope that the ‘calf squeezer’ in conjunction with 81mg of Aspirin will protect against getting a blood clot as well as, or better than, the medicine without some of the side effects of the medicine used now.
The ‘calf squeezer’ is thought to work in two ways. First, by squeezing the calf it helps return blood to the heart. Second, when the calf is squeezed, chemicals are sent into the blood, which helps the body keep clots from forming.
The ‘calf squeezer’ and the medicine used in this research are not experimental and have been approved by the U.S. Food and Drug Administration (FDA) for general use.
A total of five institutions have been asked to participate in this study, and 480 patients will be enrolled. One hundred patients will be enrolled here at HSS.
Inclusion:
a. Adult patient (Age >18)
b. Patient intended to undergo elective primary unilateral THA
c. Patient is able and willing to follow instructions of care after surgery
d. Patient is able and willing to sign the Informed consent
Exclusion:
1. Patient who has a known coagulation disorder
2. Patient currently treated with anticoagulant medications
3. Patient with known thrombophilia.
4. Patient with current signs and symptoms of or history of DVT/PE
5. Patient who is uncooperative or unable to follow instructions
6. Patient currently suffering from a solid tumor malignancy.
7. Patient with active peptic disease.
8. Patient with known allergy to Aspirin or Enoxaparin
9. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.
10. Pregnant women
11. Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period
12. Patient who is participating in another clinical drug trial
Kristin Foote
footek@hss.edu
212.774.7278