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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183479
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Weiyun Chen, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Scoliosis; Adolescence Bleeding Surgery Drug: Fibrinogen Concentrate Human Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: After randomization, the unblinded independent investigator will be in charge of fibrinogen concentrate (drug) or placebo preparation, which will be performed in a laboratory next to the operating room. When the patient meets the inclusion criteria and is enrolled in the study, the functional fibrinogen tests will be done in the same laboratory by the same researcher, and drug or placebo will be prepared in sterile bags with opaque covers afterwards. Fibrinogen concentrate will be diluted in 100mL of sterile water or an equivalent volume of 0.9% saline solution as placebo and will be delivered to the operating room by the investigator. The anesthesiologists, the surgical staff, and the patients will all be blinded.
Primary Purpose: Prevention
Official Title: The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Scoliosis
Drug Information available for: Fibrinogen

Arm Intervention/treatment
Experimental: Treatment group
The patients in treatment group will receive Fibrinogen Concentrate Human administration.
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.
Other Name: FIBRORAAS

Placebo Comparator: Control group
The patients in control group will be administered with normal saline solution as placebo.
Drug: Normal saline
100mL normal saline will be administered to patients in control group as placebo




Primary Outcome Measures :
  1. Perioperative blood loss [ Time Frame: hospital stay up to 30 days ]
    the total amount of intraoperative and postoperative blood loss


Secondary Outcome Measures :
  1. Perioperative blood loss per fused level [ Time Frame: hospital stay up to 30 days ]
    amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels

  2. Intraoperative blood loss [ Time Frame: From the time of skin incision until wound closure, assessed up to 12 hours ]
    the amount of intraoperative blood loss

  3. Intraoperative blood loss per fused level [ Time Frame: From the time of skin incision until wound closure, assessed up to 12 hour ]
    amount of intraoperative blood loss divided by the number of surgical fused levels

  4. Postoperative drainage [ Time Frame: hospital stay up to 30 days ]
    the amount of postoperative drainage

  5. Postoperative drainage per fused level [ Time Frame: hospital stay up to 30 days ]
    amount of postoperative drainage divided by the number of surgical fused levels

  6. Perioperative allogeneic red blood cell (RBC) transfusion [ Time Frame: hospital stay up to 30 days ]
    total units of RBC transfused perioperatively

  7. Perioperative plasma transfusion [ Time Frame: hospital stay up to 30 days ]
    total volume of plasma transfused perioperatively

  8. Perioperative platelets transfusion [ Time Frame: hospital stay up to 30 days ]
    total units of platelets transfused perioperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183479


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Weiyun Chen, MD Peking Union Medical College Hospital

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Responsible Party: Weiyun Chen, Principal Investigator, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03183479    
Other Study ID Numbers: PUMCH-FC
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data is anticipated to be shared with potential collaborators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Anticipated that data from the study will become available within 5 years after publication of main data.
Access Criteria: Data would only be shared with IRB approved collaborators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weiyun Chen, Peking Union Medical College Hospital:
adolescent idiopathic scoliosis
fibrinogen concentrate
perioperative blood loss
transfusion
Additional relevant MeSH terms:
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Scoliosis
Hemorrhage
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases