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临床试验/CTRI/2017/08/009324
CTRI/2017/08/009324已完成不适用

A Comparative evaluation of effect of colloid and crystalloid preloading on coagulation usingthromboelastography in patients undergoing caesarean section under spinal anaesthesia

Deen Dayal Upadhyay Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年9月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
To evaluate any effect on coagulation in

研究概览

简要总结

Ninety term pregnant patients with a single live foetus were included in the study. All patients were divided into 3 groups

with 30 patients in each group receiving preloading with ringer lactate/ 10% hydroxyethyl starch/ gelofusine. Thromboelastography analysis was done before and after preloading for these parameter-R time(time from initiation of test to beginning of clot formation), K time(time until amplitude reaches up to 20mm), Alpha angle( acceleration of fibrin build up and cross linking) and Maximum amplitude(maximum strength of clot). Thromboelastographic variables R time were decrease in all three groups. There was no statistically significant change in K time after preload. There was significant reduction in alpha angle after preloading with 10% hydroxyethyl starch. Among intergroup significant change in mean alpha angle was found when 10% hydroxyethyl starch compared with ringer lactate and gelofusine.There was significant reduction in maximum amplitude (MA) after preloading with 10% hydroxyethyl starch and gelofusine. Among intergroup, significant change in mean maximum amplitude when 10% hydroxyethyl starch was compared with ringer lactate and gelofusine compared with ringer lactate. Preloading in term parturient with ringer lactate, 10% hydroxyethyl starch and gelofusine affects blood coagulability. Ringer lactate infusion causes a very mild hypercoagulable state while both colloids (10% hydroxyethyl starch and gelofusine) produce mild hypocoagulable state in comparison to pretransfusion status. However all thromboelastographic parameters values were within their respective normal range.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Women with term pregnancy with a single live foetus, in age group of 20-40 years(noted as completed years) weighing 50-75 kg belonging to ASA grade I, scheduled for elective caesarean section under spinal anesthesia.

排除标准

  • Patient with medical co morbidity hypertension/diabetes/liver disease /cardiac disease/neurological disease, pre-existing hematological or coagulation disorder, spinal deformity, patient receiving aspirin/non steroidal anti inflammatory disease/any other anti-coagulation drug, infection over back, multiple and complicated pregnancy and patients already receiving any intravenous fluid before reaching preoperative room were excluded from the study.

结局指标

主要结局

To evaluate any effect on coagulation in

时间窗: TEG analysis was done within 01 minute of taking the sample, before fluid preloading. Fluid preloading with either Ringer Lactate, 10% HydroxyethylStarch or Gelofusine was administered over 30 minutes in the preoperative room. Blood sample was again taken after fluid pre loading, and TEG analysis done within 01 minute.

pregnant patients on preloading with crystalloid

时间窗: TEG analysis was done within 01 minute of taking the sample, before fluid preloading. Fluid preloading with either Ringer Lactate, 10% HydroxyethylStarch or Gelofusine was administered over 30 minutes in the preoperative room. Blood sample was again taken after fluid pre loading, and TEG analysis done within 01 minute.

(ringer lactate) and colloids (hydroxyethyl starch

时间窗: TEG analysis was done within 01 minute of taking the sample, before fluid preloading. Fluid preloading with either Ringer Lactate, 10% HydroxyethylStarch or Gelofusine was administered over 30 minutes in the preoperative room. Blood sample was again taken after fluid pre loading, and TEG analysis done within 01 minute.

& gelofusine)

时间窗: TEG analysis was done within 01 minute of taking the sample, before fluid preloading. Fluid preloading with either Ringer Lactate, 10% HydroxyethylStarch or Gelofusine was administered over 30 minutes in the preoperative room. Blood sample was again taken after fluid pre loading, and TEG analysis done within 01 minute.

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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