The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery

Conditions
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Bleeding, Scoliosis; Adolescence, Surgery

Intervention / Treatment
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* Drug: Fibrinogen Concentrate Human
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>The patients in treatment group will receive Fibrinogen Concentrate Human administration. | Drug: Fibrinogen Concentrate Human<br>* 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.<br>* Other names: FIBRORAAS;|
| Placebo Comparator: Control group<br>The patients in control group will be administered with normal saline solution as placebo. | Drug: Normal saline<br>* 100mL normal saline will be administered to patients in control group as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | the total amount of intraoperative and postoperative blood loss | hospital stay up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss per fused level | amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels | hospital stay up to 30 days | 
| Intraoperative blood loss | the amount of intraoperative blood loss | From the time of skin incision until wound closure, assessed up to 12 hours | 
| Intraoperative blood loss per fused level | amount of intraoperative blood loss divided by the number of surgical fused levels | From the time of skin incision until wound closure, assessed up to 12 hour | 
| Postoperative drainage | the amount of postoperative drainage | hospital stay up to 30 days | 
| Postoperative drainage per fused level | amount of postoperative drainage divided by the number of surgical fused levels | hospital stay up to 30 days | 
| Perioperative allogeneic red blood cell (RBC) transfusion | total units of RBC transfused perioperatively | hospital stay up to 30 days | 
| Perioperative plasma transfusion | total volume of plasma transfused perioperatively | hospital stay up to 30 days | 
| Perioperative platelets transfusion | total units of platelets transfused perioperatively | hospital stay up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent idiopathic scoliosis, fibrinogen concentrate, perioperative blood loss, transfusion