By a News Reporter-Staff News Editor at Biotech Week -- New research on Clinical Research is the subject of a report. According to news reporting originating in New York City, New York, by NewsRx journalists, research stated, "Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of human fibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty."
The news reporters obtained a quote from the research from Hospital for Special Surgery, "It was hypothesized that the use of human fibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6 weeks and complications after surgery. Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test. There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780 +/- A 378 mL in the fibrinogen group compared with 673 +/- A 301 mL in the control group (p = 0.029), but the hemoglobin drop at Day 2 was 3.47 +/- A 1.53 g/L in the fibrinogen group and 3.84 +/- A 1.24 g/Ll in the control group (p = 0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups. The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis. Level I, therapeutic study."
According to the news reporters, the research concluded: "See Guidelines for Authors for a complete description of levels of evidence."
For more information on this research see: Intraarticular Fibrinogen Does Not Reduce Blood Loss in TKA: A Randomized Clinical Trial. Clinical Orthopaedics and Related Research, 2014;472(1):272-276. Clinical Orthopaedics and Related Research can be contacted at: Springer, 233 Spring St, New York, NY 10013, USA. (Springer - www.springer.com; Clinical Orthopaedics and Related Research - www.springerlink.com/content/0009-921x/)
Our news correspondents report that additional information may be obtained by contacting T.J. Heyse, Hospital for Special Surgery, Adult Reconstruct & Joint Replacement Div, New York, NY 10021, United States. Additional authors for this research include S.B. Haas, D. Drinkwater, S. Lyman, H.J. Kim, B.A. Kahn and M.P. Figgie (see also Clinical Research).
Keywords for this news article include: Surgery, Fibrinogen, Therapeutics, New York City, United States, Clinical Research, Knee Arthroplasty, Protein Precursors, Acute-Phase Proteins, Adverse Drug Reaction, Coagulation Modifiers, Orthopedic Procedures, North and Central America, Blood Coagulation Factors, Clinical Trials and Studies
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