The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
Allogeneic blood products transfusions are often necessary to treat perioperative bleeding in
 patients undergoing complex scoliosis surgeries. A prospective, randomized trial is designed
 to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion
 in patients undergoing scoliosis surgery. Eligible patients will be randomly assigned to
 treatment group (fibrinogen concentrate infusion) and control group (normal saline infusion),
 and functional fibrinogen will be measured to guide the infusion of fibrinogen concentrate.
 Perioperative blood loss, intraoperative blood loss, and the amount of perioperative
 allogeneic blood transfusion will be compared between the two groups to determine the effect
 of fibrinogen concentrate infusion.
This is a prospective, randomized, double-blinded, placebo controlled trial to evaluate the
 effects of fibrinogen concentrate infusion on perioperative blood loss and the amount of
 perioperative allogeneic blood transfusion in patients undergoing scoliosis surgery.

 Recently, the inherent risks of blood, along with the continued rise in blood costs,
 activated the development and use of alternatives to blood transfusion. Fibrinogen
 concentrate may limit postoperative bleeding and lead to a significant reduction in
 allogeneic blood products transfusions in cardiac surgery and craniosynostosis surgery.
 However, the effect of fibrinogen concentrate in scoliosis surgery is still uncertain.
 Therefore, a prospective, randomized trial is designed to evaluate if the infusion of
 fibrinogen concentrate may reduce allogeneic blood transfusion in patients undergoing
 scoliosis surgery.

 Patients older than 12y/o with adolescent idiopathic scoliosis planed for elective posterior
 scoliosis correction surgery will be enrolled for this study after informed consent. Patients
 will be randomly assigned to a treatment group or a control group. Functional fibrinogen will
 be measured using TEG 5000 (Haemoscope Corp, IL, USA) at the start of surgery and the results
 of FLEV and MA will be recorded. After pedicle screw placement, a second functional
 fibrinogen will be measured and the patients in treatment group will receive fibrinogen
 concentrate (FIBRORAAS, Shanghai RAAS Blood Products Co, Ltd, Shanghai, China) 30mg kg-1. For
 safety concern, the maximum fibrinogen concentrate administration for each individual shall
 not exceed either 2g. Patients in the control group will receive placebo treatment with
 normal saline. After 15 minutes from fibrinogen concentrate or placebo administration, a
 third functional fibrinogen measurement will be performed to assess the effect of treatment.
 The following treatment will be guaranteed by the standard protocol in the presence of
 ongoing bleeding.

 Data includes all the demographics, preoperative conditions, procedure details,
 intraoperative data, and outcome measurements will be recorded. Additional data including
 FLEV and MA value, as well as fibrinogen values both preoperatively and at the arrival at
 wards. The primary endpoint of this study will be the total perioperative blood loss, and
 secondary endpoints will include: perioperative blood loss per fused level, intraoperative
 blood loss per fused level, the amount of postoperative drainage, the amount of postoperative
 drainage per fused level, total units of perioperative allogeneic pRBCs transfused, total
 volume of FFP transfused, total PLT units transfused. Safety endpoints will include operative
 mortality and perioperative thromboembolic complications.
Inclusion Criteria:

 -  patients diagnosed as adolescent idiopathic scoliosis

 -  planed for elective posterior scoliosis correction surgery at Peking Union Medical
 College Hospital

 Exclusion Criteria:

 -  preoperative anemia

 -  preoperative congenital or acquired coagulopathy

 -  ongoing anticoagulation therapy or drug intake that could cause bleeding

 -  clinical signs or diagnosis of acute thromboembolism

 -  emergency surgery

 -  redo surgery