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NCT03183479

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

Completed Phase 4 Last updated 2 March 2020
What this trial tests

Phase 4 trial testing Fibrinogen Concentrate Human in Scoliosis; Adolescence in 102 participants. Completed in 31 August 2019.

Timeline
14 June 2017
Primary endpoint
31 August 2019
31 August 2019

Quick facts

Lead sponsorPeking Union Medical College Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment102
Start date14 June 2017
Primary completion31 August 2019
Estimated completion31 August 2019
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 12 to 18, any sex, with Scoliosis; Adolescence or Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia.
    Fabes J, Brunskill SJ, Curry N, Doree C, et al · · 2018 · cited 11× · PMID 30582172 · DOI 10.1002/14651858.cd010649.pub2

Verify or expand the search:

Other trials of Fibrinogen Concentrate Human

Trials testing the same drug.

Other recruiting trials for Scoliosis; Adolescence

Currently open trials in the same condition.

Other Peking Union Medical College Hospital trials

Trials by the same sponsor.

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