此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery

2018年11月7日 更新者:Corniche Hospital

Thromboelastometry (ROTEM) For Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery: An Observational Study

Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable state is more evident in morbidly obese pregnant women as opposed to their non-obese counterparts. The aim of this study is to investigate the change in coagulation status of morbidly obese and non-obese pregnant women following cesarean section delivery using thromboelastometry. This observational study would also make it possible to calculate the sample size for a future prospective controlled clinical trial to compare the incidence of Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts. To the best of our knowledge, no other work has been done any in this area.

研究概览

地位

完全的

详细说明

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).

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Term pregnant women presenting for elective cesarean section under spinal anaesthesia

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
morbidly obese pregnant
Term pregnant women with BMI more than 40
non obese pregnant
Term pregnant women with BMI less than 30

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
大体时间:8 hours
"G" value will be calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2
8 hours

次要结果测量

结果测量
措施说明
大体时间
EXTEM clotting time and clot formation time in seconds.
大体时间:8 hours
measured ROTEM thromboelastometry variables
8 hours
EXTEM maximum clot firmness in millimeters
大体时间:8 hours
measured ROTEM thromboelastometry variable
8 hours
INTEM clotting time and clot formation time in seconds.
大体时间:8 hours
measured ROTEM thromboelastometry variables
8 hours
INTEM maximum clot firmness in millimeters
大体时间:8 hours
measured ROTEM thromboelastometry variable
8 hours
FIBTEM maximum clot firmness in millimeters
大体时间:8 hours
measured ROTEM variable
8 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mohamed Samy Abdel Raheem, FRCA、Consultant Anaesthetist
  • 首席研究员:Tarek Ansari, FFARCSI、Consultant Anaesthetist
  • 首席研究员:Waleed Riad, MD、Consultant Anaesthetist

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年11月15日

初级完成 (实际的)

2017年9月30日

研究完成 (实际的)

2017年10月30日

研究注册日期

首次提交

2016年1月17日

首先提交符合 QC 标准的

2016年3月23日

首次发布 (估计)

2016年3月24日

研究记录更新

最后更新发布 (实际的)

2018年11月8日

上次提交的符合 QC 标准的更新

2018年11月7日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ch23031401

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

No plan

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅