- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02718924
Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery
Thromboelastometry (ROTEM) For Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery: An Observational Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Following institutional ethical committee approval, 20 morbidly obese (BMI>40) and 20 non-obese (BMI < 30) parturients undergoing elective low segment cesarean section (LSCS) delivery under spinal subarachnoid block will be recruited into the study. A written informed consent will be obtained from all parturients prior to inclusion. All patients will receive an information sheet at the preoperative assessment visit to inform them about this study. Patients with a history of past or current thromboembolism will be excluded from the study as well as those with liver disease and those already on anticoagulant/anti-platelet therapy for repeated miscarriage or other indications. History of thromboembolism is defined as an arterial or deep venous thrombosis, catheter thrombosis, or pulmonary embolism diagnosed by ultrasound or spiral computed tomography (CT). Preoperative baseline full blood count and clotting profile will be done. Parturients with abnormal platelet count or coagulation results and those who will need conversion to general anesthesia will be excluded.
Data and sample collection Preoperative BMI, co-existing morbidities and laboratory test results including INR, PTT and platelet count as well as operative time and postoperative clinical or radiological evidence of thromboembolism will be recorded. A blood sample will be collected for ROTEM analysis prior to establishing the block (baseline), immediately after surgery and 8 hours later.
ROTEM analysis
Coagulability will be assessed using the ROTEM thromboelastometry analyzer (The ROTEM® delta, Tem Systems Inc.®, Munich, Germany). Extrinsic rotational thromboelastometry (EXTEM), intrinsic rotational thromboelastometry (INTEM) and FIBTEM will be measured for each blood sample. Clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF) will be recorded. Total clot strength will be assessed by "G" value as calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2 . G has been shown to be valuable in diagnosing hypo- and hypercoagulability . In non-obstetric cohorts, hypercoagulability was defined as a G value of ≥ 11.7 dynes/cm2 and hypocoagulability as a G value of <5.0 dynes/cm2 (values provided by manufacturer).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Abu Dhabi, Emirats Arabes Unis, 3788
- Corniche Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- pregnant women at term presenting for cesarean section under spinal anaesthesia with BMI less than 30 and more than 40
Exclusion Criteria:
- Patients with BMI between 30 and 40 BMI
- Patients with a history of past or current thromboembolism.
- Patients with history of liver disease and those on anticoagulant/anti-platelet therapy
- Patients who requires perioperative blood transfusion
- Patients having General anaesthesia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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morbidly obese pregnant
Term pregnant women with BMI more than 40
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non obese pregnant
Term pregnant women with BMI less than 30
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
Délai: 8 hours
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"G" value will be calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2
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8 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
EXTEM clotting time and clot formation time in seconds.
Délai: 8 hours
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measured ROTEM thromboelastometry variables
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8 hours
|
|
EXTEM maximum clot firmness in millimeters
Délai: 8 hours
|
measured ROTEM thromboelastometry variable
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8 hours
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INTEM clotting time and clot formation time in seconds.
Délai: 8 hours
|
measured ROTEM thromboelastometry variables
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8 hours
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INTEM maximum clot firmness in millimeters
Délai: 8 hours
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measured ROTEM thromboelastometry variable
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8 hours
|
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FIBTEM maximum clot firmness in millimeters
Délai: 8 hours
|
measured ROTEM variable
|
8 hours
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohamed Samy Abdel Raheem, FRCA, Consultant Anaesthetist
- Chercheur principal: Tarek Ansari, FFARCSI, Consultant Anaesthetist
- Chercheur principal: Waleed Riad, MD, Consultant Anaesthetist
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ch23031401
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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