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

NCT03183479 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-03-02

No results posted yet for this study

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.

Conditions

  • Scoliosis; Adolescence
  • Bleeding
  • Surgery

Interventions

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.

DRUG

Normal saline

100mL normal saline will be administered to patients in control group as placebo

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Weiyun Chen, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03183479 on ClinicalTrials.gov