Skip to main content
OpenTrials
Completed

NCT Number: NCT03137745

Coagulation Profile of Patients Undergoing CRS(Cytoreductive Surgery) and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Haematological Abnormality Body Temperature Changes Fever Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA 1&2
  • Undergoing CRS with HIPEC

Exclusion criteria

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

Treatment and study plan

thromboelastography

Other

thromboelastography was done pre HIPEC ,post HIPEC and first and second postoperative days

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 3, 2017
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.