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

Haematological Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137745
• Other study ID #: RGCI ID:395/AN/FSP-08
• Status: Completed
• Phase: N/A
• First received: April 26, 2017
• Last updated: May 2, 2017
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA 1&2

• Undergoing CRS with HIPEC

Exclusion Criteria:

• extremities of age

• patients with coagulopathy

• patients on anticoagulant preoperatively sever organ dysfunctions

Related Conditions & MeSH terms

• Fever
• Haematological Abnormality

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

References & Publications (2)

Korakianitis O, Daskalou T, Alevizos L, Stamou K, Mavroudis C, Iatrou C, Vogiatzaki T, Eleftheriadis S, Tentes AA. Lack of significant intraoperative coagulopathy in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy ( — View Citation

Sheshadri DB, Chakravarthy MR. Anaesthetic Considerations in the Perioperative Management of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Indian J Surg Oncol. 2016 Jun;7(2):236-43. doi: 10.1007/s13193-016-0508-2. Epub 2016 Feb 20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of thromboelastograph values with standard coagulation tests	arterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and patial thromboplastin time( seconds)	1.5 hours after HIPEC
Secondary	comparison of various thromboelastograph values with standard coagulation tests	arterial samples were taken for thromboelastography and prothrombin time(seconds), fibrinogen( mg) and partial thromboplastin time(seconds)	24hours and 48 hours after HIPEC