The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
Condition: Scoliosis; Adolescence; Bleeding; Surgery
MeSH terms: Scoliosis; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fibrinogen Concentrate Human; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): After start of surgery when all pedicle screws are placed, the patients in treatment group will receive fibrinogen concentrate 30mg kg-1. For safety concern, functional fibrinogen will be measured and the maximum fibrinogen concentrate administration for each individual shall not exceed 2g. Fibrinogen concentrate will be diluted in 100mL of sterile water and then be administered to patients.; 100mL normal saline will be administered to patients in control group as placebo
Other intervention name(s): FIBRORAAS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: adolescent idiopathic scoliosis; fibrinogen concentrate; perioperative blood loss; transfusion