- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Abu Dhabi, United Arab Emirates, 3788
- Corniche Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
Time Frame: 8 hours
|
"G" value will be calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EXTEM clotting time and clot formation time in seconds.
Time Frame: 8 hours
|
measured ROTEM thromboelastometry variables
|
8 hours
|
EXTEM maximum clot firmness in millimeters
Time Frame: 8 hours
|
measured ROTEM thromboelastometry variable
|
8 hours
|
INTEM clotting time and clot formation time in seconds.
Time Frame: 8 hours
|
measured ROTEM thromboelastometry variables
|
8 hours
|
INTEM maximum clot firmness in millimeters
Time Frame: 8 hours
|
measured ROTEM thromboelastometry variable
|
8 hours
|
FIBTEM maximum clot firmness in millimeters
Time Frame: 8 hours
|
measured ROTEM variable
|
8 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Samy Abdel Raheem, FRCA, Consultant Anaesthetist
- Principal Investigator: Tarek Ansari, FFARCSI, Consultant Anaesthetist
- Principal Investigator: Waleed Riad, MD, Consultant Anaesthetist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ch23031401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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