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NCT Number: NCT03956836

Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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%

Exclusion criteria

  • - Exclusion criteria: were severe cardiovascular or respiratory disease,
  • - 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.

Treatment and study plan

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

Other names: ROTEM, PFA-100

Primary outcomes

  1. Variations of CT-ROTEM

    Time frame: 48 hours

    variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery

  2. Variations of MCF-ROTEM

    Time frame: 48 hours

    variations in maximum clotting firmness of ROTEM 48 hours post surgery

  3. Variations of PFA-100

    Time frame: 48 hours

    variations in COL-EPI (platelet function) from of 48 hours post surgery

  4. Variations of Factor XIII

    Time frame: 48 hours

    variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery

  5. Variations of von Willebrand

    Time frame: 48 hours

    variations in von Willebrand Concentration from 48 hours post surgery

Secondary outcomes

  1. Transfusion of red blood cells

    Time frame: 20 days

    number of packed red blood cells and percentage of transfused patients

Sponsors and collaborators

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Other

Registry information

Official study title

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

Acronym: HIPEC-COAG

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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