Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty.
The purpose of this study was to evaluate the effectiveness of a collagen/thrombin and autologous platelet hemostatic agent in preventing blood loss during primary total knee arthroplasty. This prospective, double-blinded, randomized study was designed to enroll a total of 100 patients. Patients were randomized 1:1 to either the treatment arm (standard hemostasis plus study product) or the control arm (standard hemostasis alone). Transfusion requirements, as determined by a blinded investigator using standardized criteria, were significantly lower in the treatment group (no blood transfusions) compared with the control group (5 transfusions; P = .007). These data support the addition of the study product to prevent blood transfusions after primary total knee arthroplasty.
Department of Orthopaedic Surgery-A41, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Michael R
MR
Bloomfield
Alison K
AK
Klika
Robert M
RM
Molloy
Mark I
MI
Froimson
Viktor E
VE
Krebs
Wael K
WK
Barsoum
D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects* / Q000379:methods; D003094:Collagen / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D013917:Thrombin / Q000627:therapeutic use*
D003094:Collagen; D013917:Thrombin