The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedMarch 2, 2020
February 1, 2020
2.2 years
June 5, 2017
February 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perioperative blood loss
the total amount of intraoperative and postoperative blood loss
hospital stay up to 30 days
Secondary Outcomes (8)
Perioperative blood loss per fused level
hospital stay up to 30 days
Intraoperative blood loss
From the time of skin incision until wound closure, assessed up to 12 hours
Intraoperative blood loss per fused level
From the time of skin incision until wound closure, assessed up to 12 hour
Postoperative drainage
hospital stay up to 30 days
Postoperative drainage per fused level
hospital stay up to 30 days
- +3 more secondary outcomes
Study Arms (2)
Treatment group
EXPERIMENTALThe patients in treatment group will receive Fibrinogen Concentrate Human administration.
Control group
PLACEBO COMPARATORThe patients in control group will be administered with normal saline solution as placebo.
Interventions
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
Eligibility Criteria
You may qualify if:
- patients diagnosed as adolescent idiopathic scoliosis
- planed for elective posterior scoliosis correction surgery at Peking Union Medical College Hospital
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
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.
PMID: 32500569DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiyun Chen, MD
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 12, 2017
Study Start
June 14, 2017
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
Coded data is anticipated to be shared with potential collaborators.