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Study: Collagen/thrombin hemostasis gel is not warranted for routine THA
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NEW ORLEANS — Investigators of a level 1 study from the Cleveland Clinic discovered no statistical difference in transfusion events or units transfused between cementless total hip arthroplasty patients who underwent the use of a collagen thrombin, fibrinogen and autologous platelet gel for a hemostatic adjuvant compared to a control group using standard hemostatic methods.
“Vitagel, in a healthy patient, used in the setting of a routine cementless total hip, does not seem to make a significant clinical difference in terms of reducing first-time transfusion events,” David M. Joyce, MD, currently with the Orthopaedic Trauma Department of Vanderbilt University in Nashville, said during a presentation at the American Academy of Orthopaedic Surgeons Annual Meeting. “The hemoglobin level was significantly different; however, our transfusion rate was not significantly different between the two groups that were tested.”
The researchers from the Cleveland Clinic compared 60 patients who were given the hemostatic agent, Vitagel (Stryker; Kalamazoo, Mich.), with a control group of 49 patients who received standard hemostasis. All patients underwent cementless total hip arthroplasty between 2010 and 2012. The investigators excluded patients who had deep vein thrombosis (DVT), rheumatic conditions, coagulation abnormalities or low preoperative hemoglobin levels (<8.5 gm/dL). The patients and investigators were blinded to the patients’ allocation to treatment.
The Vitagel was made of microfibular collagen thrombin mixed with the patient’s platelets. “The mechanism forms a hemostatic scaffold and is used as a topical hemostatic agent,” Joyce said. “It is not meant to stop major bleeding vessels, but instead stop some of the small capillaries and raw bleeding surfaces and perioperative oozing that continues after surgery.”
More patients underwent transfusion in the control group (14.3%) compared to the Vitagel group (8.3%), but this difference was not statistically significant. The average amount of transfused units of blood was not significantly different with an average of 2.2 units in the Vitagel group compared to 1.6 units in the control group. Hemoglobin levels were not significantly different at 0 days immediately postoperatively, however at postoperative day 1, day 2 and day 3, hemoglobin levels were statistically significantly higher in the Vitagel group compared to the control group (10 vs. 9.2; 9.6 vs. 9.1; 9.5 vs. 8.7, respectively). There was no difference in SF-12 quality of life and Hip Disability and Osteoarthritis Outcome scores.
“We do not feel this product is clinically warranted for use in all total hips and further study would be needed to justify its use in patients with a higher risk of bleeding such as in revisions,” he said. – by Renee Blisard Buddle