Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery (TXA-CRT)
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial
The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.
PATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.
Group A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.
Group B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.
Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.
STATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Alava
-
Vitoria-Gasteiz, Alava, Espagne, 01009
- Txagorritxu Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 years or more
- ASA I-III
- No allergies tranexamic acid
- Informed consent signed by patient
Exclusion Criteria:
- Pregnancy or lactation.
- severe vascular ischemia (coronary or peripheral)
- previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)
- coagulopathy
- Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension
- Hemoglobine <10
- moderate renal impairment (creatinine> 2)
- Cirrhosis
- contraindication to prophylaxis with enoxaparin
- Patients with a history of seizures.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: A
Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. |
Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. |
|
Expérimental: B
Group B: 1st dose: 10mg/kg of TXA (tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration. |
Group B: 1st dose: 10mg/kg of TXA(tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration. |
|
Comparateur placebo: C
Placebo
|
Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery. 2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
blood loss (ml)
Délai: 4 hours
|
4 hours
|
|
blood loss 8 hours (ml)
Délai: 8 hours
|
8 hours
|
|
blood loss 24 hours (ml)
Délai: 24 hours
|
24 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Borja Barrachina, MD, Osakidetza-Basque Country Health Service
- Chaise d'étude: Cesar Valero, MD, Osakidetza-Basque Country Health Service
- Chaise d'étude: Amanda Lopez, pharmacist, Osakidetza-Basque Country Health Service
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TXA-CRT
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