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NCT03183479
The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
Phase 4 trial testing Fibrinogen Concentrate Human in Scoliosis; Adolescence in 102 participants. Completed in 31 August 2019.
31 August 2019
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 102 |
| Start date | 14 June 2017 |
| Primary completion | 31 August 2019 |
| Estimated completion | 31 August 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fibrinogen Concentrate Human — full drug profile →
- Normal saline
Conditions studied
- Scoliosis; Adolescence — all drugs for Scoliosis; Adolescence →
- Bleeding — all drugs for Bleeding →
- Surgery — all drugs for Surgery →
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):
-
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:
- PubMed search for NCT03183479
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Fibrinogen Concentrate Human
Trials testing the same drug.
- NCT05391412 — Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery · Phase 4 · unknown
- NCT05091684 — Administration of Fibrinogen Concentrate for Refractory Bleeding · Phase 2 · terminated
- NCT04434001 — ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery · Phase 2 · terminated
- NCT03784794 — Patient Blood Management for Massive Obstetric Hemorrhage · NA · completed
Other recruiting trials for Scoliosis; Adolescence
Currently open trials in the same condition.
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- NCT05819034 — Conservative Management for Adolescent Idiopathic Scoliosis · NA · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
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- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03183479 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
- Last refreshed: 2 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03183479.
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