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
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Abu Dhabi、アラブ首長国連邦、3788
- Corniche Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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EXTEM clotting time and clot formation time in seconds.
時間枠: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
時間枠: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.
時間枠: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
時間枠: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
時間枠:8 hours
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measured ROTEM variable
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8 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Mohamed Samy Abdel Raheem, FRCA、Consultant Anaesthetist
- 主任研究者:Tarek Ansari, FFARCSI、Consultant Anaesthetist
- 主任研究者:Waleed Riad, MD、Consultant Anaesthetist
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。