A Prospective Study to Evaluate the Effectiveness of a Haemostatic Agent in Primary Unilateral Total Hip Arthroplasty

Completed · Not applicable

Conditions studied: Arthritis

In brief

This is a prospective, randomized, controlled, single-center study to assess the effectiveness of Vitagel, a surgical hemostat, in primary unilateral total hip arthroplasty (THA). This will be an inter-patient controlled study involving one-hundred-ten subjects. Vitagel will be used in a randomly selected cohort of fifty-five patients undergoing primary unilateral THA procedures; a control group of fifty-five patients will not receive Vitagel or any other hemostatic agent except those that are standard during a primary THA. The study will evaluate the effectiveness of Vitagel in reducing intra- and post-operative bleeding.

Key facts

Study ID

NCT01285024

Run by

The Cleveland Clinic

People needed

109

Starts

2010-12-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are scheduled for a primary unilateral THA;
• Are able and willing to provide voluntary written informed consent for participation in the study;
• Are between the ages of 18 and 85 at the time of surgery;
• Are willing to comply with all aspects of the treatment and evaluation period

You may not qualify if…

• Are known to be sensitive to any materials of bovine origin;
• Are undergoing a bilateral or revision THA;
• Patients predonating autologous blood.
• Patients with a preoperative platelet count of less than 100,000.
• Patients with a previous history of venous thromboembolism or deep vein thrombosis
• Medical condition requiring anticoagulation
• Currently using Coumadin
• History of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia
• Have a history of rheumatoid arthritis or inflammatory arthritis;
• Peripheral vascular disease.
• Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
• Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR is greater than 1.3 or APTT greater than 32.4
• Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;
• Have a systemic infection or infection at site of surgery;
• Are a prisoner; and/or
• Are pregnant or nursing.
• Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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