| CTRI Number |
CTRI/2017/08/009324 [Registered on: 09/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between effect of different type of intravenous fluids on blood
clotting (transformation from liquid to semi-solid/solid state) in caesarean delivery (surgical procedure to
deliver baby) patients using a real time monitor to measure blood clotting.
|
|
Scientific Title of Study
|
A Comparative evaluation of effect of colloid and crystalloid preloading on coagulation using
thromboelastography in patients undergoing caesarean section under spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIT MEHTA |
| Designation |
senior resident |
| Affiliation |
DeenDayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology & Critical Care,
Second Floor,
Main OT Building,
DDU Hospital,
Hari Nagar,
New Delhi-110064
Department of Anaesthesiology & Critical Care,
Second Floor,
Main OT Building,
DDU Hospital,
Hari Nagar,
New Delhi-110064
New Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
9718990114 |
| Email |
dramitmehta04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay Kumar |
| Designation |
Specialist |
| Affiliation |
DeenDayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology & Critical Care,
Second Floor,
Main OT Building,
DDU Hospital,
Hari Nagar,
New Delhi-110064
New Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
|
| Email |
ajayannu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay Kumar |
| Designation |
Specialist |
| Affiliation |
DeenDayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology & Critical Care,
Second Floor,
Main OT Building,
DDU Hospital,
Hari Nagar,
New Delhi-110064
Department of Anaesthesiology & Critical Care,
Second Floor,
Main OT Building,
DDU Hospital,
Hari Nagar,
New Delhi-110064
New Delhi
DELHI
110064
India |
| Phone |
9718990114 |
| Fax |
9718990114 |
| Email |
ajayannu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Deen Dayal Upadhyay Hospital |
| Address |
Department of Anaesthesiology & Critical Care,
DeenDayal Upadhyay Hospital, Govt. of NCT of Delhi,
Hari Nagar,
New Delhi- 110064 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Kumar |
Deen Dayal Upadhyay Hospital |
Department of Anaesthesiology & Critical Care,
DeenDayal Upadhyay Hospital, Govt. of NCT of Delhi,
Hari Nagar,
New Delhi- 110064
New Delhi
DELHI |
9718990114
9718990114
ajayannu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Deen Dayal Upadhyay Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant patient without any disease posted for
elective caesarean section, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous fluid crystalloid (ringer lactate) |
1000ml of Ringer lactate given via intravenous route over 30 minutes, only once.
Ringer lactate is a balanced salt solution containing ions of sodium 130 mEq/L, potassium 4 mEq/L, Calcium 2.7 mEq/L chloride 109 mEq/L and lactate 28 mEq/L |
| Intervention |
Intravenous fluids colloids (Hydroxyethyl starch and
Gelofusine) |
500 ml of 10% hydroxyethyl starch given via intravenous route over 30 minutes, only once.
500 ml of Gelofusine given via intravenous route over 30 minutes, only once.
Hydroxyethyl starch contains
poly (O-2- hydroxyethyl) starch
and sodium chloride its pH
adjusted with sodium hydroxide
or hydrochloric acid. Gelofusine
is a colloid plasma volume
replacement fluid based on
modified fluid gelatin. It is a
physiological plasma substitute
with iso oncotic pressure, a
physiological pH with a low
chloride content. 1000 ml of
Gelofusine contains 40 g
succinylated gelatin and its
molecular weight is 30,000
D. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate any effect on coagulation in
pregnant patients on preloading with crystalloid
(ringer lactate) and colloids (hydroxyethyl starch
& gelofusine) |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2011 |
| Date of Study Completion (India) |
10/04/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Thesis submitted |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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.
|