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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183479
• Other study ID #: PUMCH-FC
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Scoliosis
• Scoliosis; Adolescence
• Surgery

Intervention

Drug:
• Fibrinogen Concentrate Human
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.
• Normal saline
100mL normal saline will be administered to patients in control group as placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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