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- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 100730
- Peking Union Medical College Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
Autres noms:
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Comparateur 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perioperative blood loss
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perioperative blood loss per fused level
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: hospital stay up to 30 days
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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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PUMCH-FC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Formulaire de consentement éclairé (ICF)
- Rapport d'étude clinique (CSR)
- Code analytique
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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