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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Abu Dhabi, Verenigde Arabische Emiraten, 3788
- Corniche Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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EXTEM clotting time and clot formation time in seconds.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 8 hours
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measured ROTEM variable
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8 hours
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mohamed Samy Abdel Raheem, FRCA, Consultant Anaesthetist
- Hoofdonderzoeker: Tarek Ansari, FFARCSI, Consultant Anaesthetist
- Hoofdonderzoeker: Waleed Riad, MD, Consultant Anaesthetist
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ch23031401
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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