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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: 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)


Original Secondary Outcome: Same as current

Information By: Rajiv Gandhi Cancer Institute & Research Center, India

Dates:
Date Received: April 26, 2017
Date Started: March 2015
Date Completion:
Last Updated: May 2, 2017
Last Verified: April 2017