Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC) (HIPEC-COAG)

Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Cytoreductive surgery (CRC) with intraperitoneal hyperthermal chemotherapy (HIPEC) has been shown to improve survival in selected patients with peritoneal carcinomatosis. 51% of patients are transfused due to the high intraoperative blood loss caused by surgery and the appearance of a perioperative coagulopathy attributed to the loss of proteins into the peritoneal cavity, the high fluid turnover and possibly the action of hyperthermic chemotherapy. So far, the haemostatic changes described consist of a decrease in the levels of antithrombin III and the platelet count, as well as in alterations of the usual coagulation tests. Conventional coagulation tests analyze only the plasmatic phase of coagulation while viscoelastic tests, such as rotational thromboelastometry (ROTEM), reproduce the global coagulation process much more faithfully, keeping good correlation with perioperative bleeding.

Objetive:

The platelet, coagulation, von Willebrand and Factor XIII levels and function have not been consistently investigate in pre-established (fix) time periods in patients undergoing elective CRC with hyperthermia. This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder; Carcinomatosis
• Intervention / Treatment: Diagnostic test: ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII

Detailed Description

This prospective observational study aimed at investigating the variations of the values of estándar coagulation test, ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC. A control group (N=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Spain
  • Andalucia
    • Sevilla, Andalucia, Spain, 41012
      • Hospital Universitario Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of peritoneal surface malignancy of the ovarian and/or colo origin undergoing complete cytoreductive surgery (zero) combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Description

Inclusion Criteria:

1. - Consecutive patients with peritoneal surface malignancy treated with cytoreductive surgery and HIPEC in the Department of Surgery of Virgen del Rocio General Hospital
2. -All patients gave written informed consent.
3. -Age above 18 years and Karnofsky performance status scale 450%

Exclusion Criteria:

1. - Exclusion criteria: were severe cardiovascular or respiratory disease,
2. - Lower hemoglobin than 10,0 g/dL , platelet count 100,000/mm3,
3. - Renal or hepatic failure,
4. - Pregnancy,
5. - Multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variations of CT-ROTEM	variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery	48 hours
Variations of MCF-ROTEM	variations in maximum clotting firmness of ROTEM 48 hours post surgery	48 hours
Variations of PFA-100	variations in COL-EPI (platelet function) from of 48 hours post surgery	48 hours
Variations of Factor XIII	variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery	48 hours
Variations of von Willebrand	variations in von Willebrand Concentration from 48 hours post surgery	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transfusion of red blood cells	number of packed red blood cells and percentage of transfused patients	20 days

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2020
• Primary Completion (ACTUAL): March 8, 2021
• Study Completion (ACTUAL): March 8, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (ACTUAL): May 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Carcinoma
• Other Study ID Numbers: HUVirgenRocio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No