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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Abu Dhabi, Emirati Arabi Uniti, 3788
- Corniche Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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EXTEM clotting time and clot formation time in seconds.
Lasso di tempo: 8 hours
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measured ROTEM thromboelastometry variables
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8 hours
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EXTEM maximum clot firmness in millimeters
Lasso di tempo: 8 hours
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measured ROTEM thromboelastometry variable
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8 hours
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INTEM clotting time and clot formation time in seconds.
Lasso di tempo: 8 hours
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measured ROTEM thromboelastometry variables
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8 hours
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INTEM maximum clot firmness in millimeters
Lasso di tempo: 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
Lasso di tempo: 8 hours
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measured ROTEM variable
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8 hours
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mohamed Samy Abdel Raheem, FRCA, Consultant Anaesthetist
- Investigatore principale: Tarek Ansari, FFARCSI, Consultant Anaesthetist
- Investigatore principale: Waleed Riad, MD, Consultant Anaesthetist
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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 (Stima)
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
- ch23031401
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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