跳至主要内容
临床试验/CTRI/2021/06/034324
CTRI/2021/06/034324尚未招募不适用

Role of Thromboelastography parameters in Hypertensive Disorders of Pregnancy

KMC Manipal1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2021年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
181
试验地点
1
主要终点
Identification of type of coagulopathy based on scores of R value, K value, ‘a’ angle, MA, CI, Ly30

研究概览

简要总结

One of the complications occuring during pregnancy is Hypertensive disorders that can range from only high BP recording to multiple organ involvement including liver injury and bleeding disorder. Thromboelastography is a Test that examines type of bleeding disorder  that the pregnant mother has been affected with. Routine Hemostatic tests i.e PT APTT INR Platelets have been routinely used to detect coagulopathy associated with Hypertensive disorders of pregnancy which are individualised tests for the 3 different stages of hemostasis. However, Thromboelastography is a single test that can detect abnormalities of any stage of hemostasis. The benefits would be less time as it takes only one hour which would cut short the time taken to decide further management, it is one test in place of multiple tests and that the IHBT would also provide suggestions regarding the Blood type required to correct the particular type of Coagulopathy . Therefore more objective Test for assessing coagulopathy associated with Hypertensive disorders of pregnancy, result in better decision making in plan of action regarding the condition. Hence it would be beneficial if this is found to be useful it can be incorporated as a single test as a routine method for evaluation.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Singleton pregnancy with Severe Pre-eclampsia requiring immediate intervention Controls.
  • Singleton pregnancy with Pre-eclampsia that can undergo expectant management.

排除标准

  • Pre-eclampsia patients that can undergo expectant management, Multiple gestation, Any other causes of bleeding in pregnancy For Controls.
  • Multiple gestation, Any other causes of bleeding in pregnancy, Patients with severe pre eclampsia and eclampsia.

结局指标

主要结局

Identification of type of coagulopathy based on scores of R value, K value, ‘a’ angle, MA, CI, Ly30

时间窗: 4 months

• R value - Represents period of time of latency from start of test to initial fibrin formation

时间窗: 4 months

• K time - Represents time taken to achieve a certain level of clot strength - equates to amplitude 20 mm

时间窗: 4 months

• Alpha Angle Measures the rapidity of fibrin build-up and cross-linking (clot strengthening)

时间窗: 4 months

• MA - represents the ultimate strength of the fibrin clot

时间窗: 4 months

次要结局

  • Providing Blood component as per result of TEG(Further management as per protocol of hospital in high dependency unit.)

研究者

发起方
KMC Manipal
申办方类型
Private medical college

研究点 (1)

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