Coagulation Profile of Patients Undergoing CRS(Cytoreductive Surgery) and Hyperthermic Intraperitoneal Chemotherapy

May 2, 2017 updated by: Dr soumi pathak, Rajiv Gandhi Cancer Institute & Research Center, India

To Study the Changes in Coagulation Profile in Patients Undergoing CRS(CYTOREDUCTIVE SURGERY) and HIPEC(HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY)

To study the changes in coagulation profile in patients undergoing cytoreductive surgery and Hyperthermic intraperitoneal chemotherapy. The objective of the study is to determine the utility of thromboelastography in comparison to standard coagulation tests in assessing the coagulopathy in patients undergoing CRS with HIPEC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study conducted in 60 patients undergoing CRS with HIPEC in RGCIRC from march 2015- march2016 after taking permission from the institutional review board and informed written consent from the patients.

Arterial blood samples were collected before and after HIPEC and on first and second postoperative day for PT,APTT INR,TEG and ABG. Statistical analysis was done using chi square test and unpaired t- test for categorical and continuous variables. Pearson's correlation coefficient was calculated for analysing the correlation between the variables .P - value <0.05 was considered statistically significant.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM MARCH2015- MARCH 2016

Description

Inclusion Criteria:

  • ASA 1&2
  • Undergoing CRS with HIPEC

Exclusion Criteria:

  • extremities of age
  • patients with coagulopathy
  • patients on anticoagulant preoperatively sever organ dysfunctions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all patients undergoing CRS with HIPEC
thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM MARCH2015- MARCH 2016
Other: thromboelastography
thromboelastography was done pre HIPEC ,post HIPEC and first and second postoperative days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of thromboelastograph values with standard coagulation tests
Time Frame: 1.5 hours after HIPEC
arterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and patial thromboplastin time( seconds)
1.5 hours after HIPEC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of various thromboelastograph values with standard coagulation tests
Time Frame: 24hours and 48 hours after HIPEC
arterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and partial thromboplastin time(seconds)
24hours and 48 hours after HIPEC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (ACTUAL)

May 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGCI ID:395/AN/FSP-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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