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

NCT ID: NCT03137745

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Haematological Abnormality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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all patients undergoing CRS with HIPEC

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

thromboelastography

Intervention Type OTHER

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

Interventions

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thromboelastography

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA 1\&2
* Undergoing CRS with HIPEC

Exclusion Criteria

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

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role lead

Responsible Party

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Dr soumi pathak

Dr Soumi Pathak Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 27065715 (View on PubMed)

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 (HIPEC) indicates that epidural anaesthesia is a safe option. Int J Hyperthermia. 2015;31(8):857-62. doi: 10.3109/02656736.2015.1075606. Epub 2015 Oct 8.

Reference Type RESULT
PMID: 26446799 (View on PubMed)

Other Identifiers

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RGCI ID:395/AN/FSP-08

Identifier Type: -

Identifier Source: org_study_id

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