Clinical trial NCT03183479: The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
Official title: The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scoliosis; Adolescence
Bleeding
Surgery
Keywords: adolescent idiopathic scoliosis
fibrinogen concentrate
perioperative blood loss
transfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative blood loss
timeFrame: hospital stay up to 30 days
Secondary outcomes:
measure: Perioperative blood loss per fused level
timeFrame: hospital stay up to 30 days
measure: Intraoperative blood loss
timeFrame: From the time of skin incision until wound closure, assessed up to 12 hours
measure: Intraoperative blood loss per fused level
timeFrame: From the time of skin incision until wound closure, assessed up to 12 hour
measure: Postoperative drainage
timeFrame: hospital stay up to 30 days
measure: Postoperative drainage per fused level
timeFrame: hospital stay up to 30 days
measure: Perioperative allogeneic red blood cell (RBC) transfusion
timeFrame: hospital stay up to 30 days
measure: Perioperative plasma transfusion
timeFrame: hospital stay up to 30 days
measure: Perioperative platelets transfusion
timeFrame: hospital stay up to 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Weiyun Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen W, Shen J, Zhang Y, Hu A, Liang J, Ma L, Yu X, Huang Y. A randomised controlled trial of fibrinogen concentrate during scoliosis surgery. Anaesthesia. 2020 Nov;75(11):1476-1481. doi: 10.1111/anae.15124. Epub 2020 Jun 4.