- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02687204
Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients
Optimization of Enoxaparin Prophylaxis Using Real-time Anti-Factor Xa Levels in Major Reconstructive Surgery Patients
Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have substantial downstream ramifications, and the US Surgeon General and the American Society of Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries or defects after cancer excision, often involves borrowing tissue from adjacent or distant areas on the body; reconstructive surgery patients can routinely have surgical injury involving 20% or more of their total body surface area. Injury and resultant inflammation are known to increase metabolism of certain drugs, including those used to prevent VTE after surgery.
Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation. Previous research has shown that reconstructive surgery patients who are given enoxaparin after surgery are less likely to develop VTE. However, despite receiving of a standard dose of enoxaparin, many patients still develop this life-threatening complication. The investigators believe that patients metabolize enoxaparin differently based on the degree of surgical injury created during reconstruction, and seek to critically examine enoxaparin metabolism in reconstructive surgery patients. The proposed research will evaluate how enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive surgeries; the investigators will also examine whether the extent of surgical injury alters metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa) levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative aFXa levels. Further research based on these data will examine reduction in VTE risk when aFXa-driven enoxaparin dosing is used.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- University of Utah Hospitals
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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:
- Adult patients having plastic and reconstructive surgery who are placed on twice daily enoxaparin prophylaxis after surgery.
Exclusion criteria:
- Contraindication to use of enoxaparin.
- Intracranial bleeding/stroke, hematoma or bleeding disorder.
- Known heparin-induced thrombocytopenia
- Creatinine clearance ≤30mL/min
- Serum creatinine >1.6mg/dL
- Epidural anesthesia.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Enoxaparin prophylaxis
All enrolled patients will receive twice daily enoxaparin prophylaxis.
Patients with identified out of range peak anti-Xa levels will receive real time dose adjustment and will be considered as the experimental arm.
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
Autres noms:
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Expérimental: Real time dose adjustment
Patients with identified out of range peak anti-Xa levels will receive real time enoxaparin dose adjustment
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of patients with a 90-day VTE (either a 90-day DVT or 90-day PE)
Délai: 90 days
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Outcome measure number one will be deep venous thrombosis or pulmonary embolus confirmed with imaging within 90 days of the initial surgery.
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90 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of patients with a 90-day re-operative hematoma
Délai: 90 days
|
Outcome number two will be bleeding (hematoma) requiring return to the operating room within 90 days of the initial operation.
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90 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher Pannucci, MD MS, University of Utah
Publications et liens utiles
Publications générales
- Pannucci CJ, Fleming KI, Agarwal J, Rockwell WB, Prazak AM, Momeni A. The Impact of Once- versus Twice-Daily Enoxaparin Prophylaxis on Risk for Venous Thromboembolism and Clinically Relevant Bleeding. Plast Reconstr Surg. 2018 Jul;142(1):239-249. doi: 10.1097/PRS.0000000000004517.
- Pannucci CJ, Fleming KI, Momeni A, Prazak AM, Agarwal J, Rockwell WB. Twice-Daily Enoxaparin among Plastic Surgery Inpatients: An Examination of Pharmacodynamics, 90-Day Venous Thromboembolism, and 90-Day Bleeding. Plast Reconstr Surg. 2018 Jun;141(6):1580-1590. doi: 10.1097/PRS.0000000000004379.
- Pannucci CJ, Fleming KI. Comparison of face-to-face interaction and the electronic medical record for venous thromboembolism risk stratification using the 2005 Caprini score. J Vasc Surg Venous Lymphat Disord. 2018 May;6(3):304-311. doi: 10.1016/j.jvsv.2017.10.016. Epub 2018 Feb 13.
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 (Estimation)
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
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Embolie et thrombose
- Embolie
- Thrombose
- La thrombose veineuse
- Thromboembolie
- Thromboembolie veineuse
- Embolie pulmonaire
- Mécanismes moléculaires de l'action pharmacologique
- Agents fibrinolytiques
- Agents modulateurs de fibrine
- Anticoagulants
- Énoxaparine
- Énoxaparine sodique
Autres numéros d'identification d'étude
- 86052
Plan pour les données individuelles des participants (IPD)
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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
- Plan d'analyse statistique (PAS)
Informations sur les médicaments et les dispositifs, documents d'étude
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