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

NCT03956836 | Completed

• 1 other identifier: HUVirgenRocio
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coagulation Disorder; Carcinomatosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Transfusion of red blood cells

  20 days

Interventions

ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII DIAGNOSTIC_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

Also known as: ROTEM, PFA-100

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• \- Lower hemoglobin than 10,0 g/dL , platelet count 100,000/mm3,
• \- Renal or hepatic failure,
• \- Pregnancy,
• \- Multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41012, Spain

Location

MeSH Terms

Conditions

Hemostatic Disorders; Carcinoma

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Staff

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 21, 2019
• Study Start: March 27, 2020
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)