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)
1 other identifier
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedMay 5, 2017
April 1, 2017
1 year
April 26, 2017
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
comparison of various thromboelastograph values with standard coagulation tests
24hours and 48 hours after HIPEC
Study Arms (1)
all patients undergoing CRS with HIPEC
thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM MARCH2015- MARCH 2016
Interventions
thromboelastography was done pre HIPEC ,post HIPEC and first and second postoperative days
Eligibility Criteria
thromboelastography was done in 60 patients undergoing CRS with HIPEC in RGCI FROM MARCH2015- MARCH 2016
You may qualify if:
- ASA 1\&2
- Undergoing CRS with HIPEC
You may not qualify if:
- extremities of age
- patients with coagulopathy
- patients on anticoagulant preoperatively sever organ dysfunctions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 27065715BACKGROUNDKorakianitis 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.
PMID: 26446799RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Soumi Pathak Principal Investigator
Study Record Dates
First Submitted
April 26, 2017
First Posted
May 3, 2017
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 5, 2017
Record last verified: 2017-04