- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03183479
The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Beijing
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Beijing, Beijing, Cina, 100730
- Peking Union Medical College Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Treatment group
The patients in treatment group will receive Fibrinogen Concentrate Human administration.
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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.
Altri nomi:
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Comparatore placebo: Control group
The patients in control group will be administered with normal saline solution as placebo.
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100mL normal saline will be administered to patients in control group as placebo
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Perioperative blood loss
Lasso di tempo: hospital stay up to 30 days
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the total amount of intraoperative and postoperative blood loss
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hospital stay up to 30 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Perioperative blood loss per fused level
Lasso di tempo: hospital stay up to 30 days
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amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels
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hospital stay up to 30 days
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Intraoperative blood loss
Lasso di tempo: From the time of skin incision until wound closure, assessed up to 12 hours
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the amount of intraoperative blood loss
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From the time of skin incision until wound closure, assessed up to 12 hours
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Intraoperative blood loss per fused level
Lasso di tempo: From the time of skin incision until wound closure, assessed up to 12 hour
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amount of intraoperative blood loss divided by the number of surgical fused levels
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From the time of skin incision until wound closure, assessed up to 12 hour
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Postoperative drainage
Lasso di tempo: hospital stay up to 30 days
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the amount of postoperative drainage
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hospital stay up to 30 days
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Postoperative drainage per fused level
Lasso di tempo: hospital stay up to 30 days
|
amount of postoperative drainage divided by the number of surgical fused levels
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hospital stay up to 30 days
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Perioperative allogeneic red blood cell (RBC) transfusion
Lasso di tempo: hospital stay up to 30 days
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total units of RBC transfused perioperatively
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hospital stay up to 30 days
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Perioperative plasma transfusion
Lasso di tempo: hospital stay up to 30 days
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total volume of plasma transfused perioperatively
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hospital stay up to 30 days
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Perioperative platelets transfusion
Lasso di tempo: hospital stay up to 30 days
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total units of platelets transfused perioperatively
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hospital stay up to 30 days
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Collaboratori e investigatori
Pubblicazioni e link utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PUMCH-FC
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
- Modulo di consenso informato (ICF)
- Relazione sullo studio clinico (CSR)
- Codice analitico
Informazioni su farmaci e dispositivi, documenti di studio
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