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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03137745
Enrollment
60
Registered
2017-05-03
Start date
2015-03-31
Completion date
2016-03-31
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haematological Abnormality

Keywords

Thromboelastography, chemotherapy,hyperthermic

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.

Interventions

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

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA 1&2 * Undergoing CRS with HIPEC

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of thromboelastograph values with standard coagulation tests1.5 hours after HIPECarterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and patial thromboplastin time( seconds)

Secondary

MeasureTime frameDescription
comparison of various thromboelastograph values with standard coagulation tests24hours and 48 hours after HIPECarterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and partial thromboplastin time(seconds)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026