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

Completed

• Conditions: Haematological Abnormality
• Interventions: Other: thromboelastography

• Registration Number: NCT03137745
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

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 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 Timeline

• Study Start: 2015-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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