A double-blind, randomized, controlled study to explore the efficacy of rFVIIa on intraoperative blood loss and mortality in patients with severe acute pancreatitis.
BACKGROUND
Severe acute pancreatitis is a life-threatening disease. Patients with peripancreatic necrotic infection often require surgical removal of necrotic infected tissue and a wide debridement will cause blood loss and worsen the condition.


OBJECTIVE
To assess whether treatment with NovoSeven, a recombinant activated FVII (rFVIIa), could improve coagulation function and therefore reduce blood loss, blood transfusion and all-cause mortality during necrosectomy in patients with infected necrosis secondary to severe acute pancreatitis.


METHODS
Severe acute pancreatitis patients admitted to Nanjing Jinling Hospital for necrosectomy were enrolled and randomized to receive either standard treatment or standard treatment plus an intravenous infusion of rFVIIa (40μg per kilogram of body weight per hour) before operation. The prospectively defined primary end points were perioperative coagulation parameters (prothrombin time, activated partial thromboplastin time), blood transfusion unit and blood loss. The secondary end points were operation time, ICU stay and all-cause mortality at 28days after the operation.


RESULTS
A total of 64 patients were enrolled (31 in the rFVIIa group and 33 in the control group). Treatment with rFVIIa was associated with a reduction in operation time, red blood cell and fresh froze plasma transfusion, blood loss and prothrombin time compared to the control group (p<0.05 for all). Activated partial thromboplastin time and mortality were similar between the two groups (P>0.05).


CONCLUSIONS
Treatment with rFVIIa significantly improved the extrinsic coagulation function in patients with severe acute pancreatitis and was associated with decreased risk of bleeding. However, rFVIIa did not improve intrinsic coagulation or reduce over-cause mortality.


BACKGROUND
ChiCTR-TRC-1300389.
Intensive care unit, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, 155 Hanzhong Road, Nanjing 210029, Jiangsu Province, China.
Jun
J
Lu
Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350112, Fujian Province, China.
Lian-Ming
LM
Liao
Intensive care unit, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, 155 Hanzhong Road, Nanjing 210029, Jiangsu Province, China.
Yan-Xia
YX
Geng
Intensive care unit, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, 155 Hanzhong Road, Nanjing 210029, Jiangsu Province, China.
Xing
X
Wang
Department of General Surgery, Jinling Hospital, 305 Zhongshan East Road, Nanjing 210002, Jiangsu Province, China.
Zhi-Hui
ZH
Tong
Department of General Surgery, Jinling Hospital, 305 Zhongshan East Road, Nanjing 210002, Jiangsu Province, China.
Lu
L
Ke
Department of General Surgery, Jinling Hospital, 305 Zhongshan East Road, Nanjing 210002, Jiangsu Province, China. Electronic address: aztec0403@sina.com.
Wei-Qin
WQ
Li
Department of General Surgery, Jinling Hospital, 305 Zhongshan East Road, Nanjing 210002, Jiangsu Province, China.
Ning
N
Li
Department of General Surgery, Jinling Hospital, 305 Zhongshan East Road, Nanjing 210002, Jiangsu Province, China.
Jie-Shou
JS
Li
D001777:Blood Coagulation / Q000187:drug effects; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004311:Double-Blind Method; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007430:Intraoperative Care / Q000379:methods; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000188:drug therapy*; D019283:Pancreatitis, Acute Necrotizing / Q000097:blood* / Q000601:surgery*; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
Blood loss; Blood transfusion; Coagulation dysfunction; Necrosectomy; Recombinant activated factor VII; Severe acute pancreatitis