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出境医 / 临床实验 / Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC) (HIPEC-COAG)

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

Study Description
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.


Condition or disease Intervention/treatment
Coagulation Disorder Carcinomatosis 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 Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Actual Study Start Date : March 27, 2020
Actual Primary Completion Date : March 8, 2021
Actual Study Completion Date : March 8, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  1. Transfusion of red blood cells [ Time Frame: 20 days ]
    number of packed red blood cells and percentage of transfused patients


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 13, 2019
First Posted Date May 21, 2019
Last Update Posted Date March 9, 2021
Actual Study Start Date March 27, 2020
Actual Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019)
  • Variations of CT-ROTEM [ Time Frame: 48 hours ]
    variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery
  • Variations of MCF-ROTEM [ Time Frame: 48 hours ]
    variations in maximum clotting firmness of ROTEM 48 hours post surgery
  • Variations of PFA-100 [ Time Frame: 48 hours ]
    variations in COL-EPI (platelet function) from of 48 hours post surgery
  • Variations of Factor XIII [ Time Frame: 48 hours ]
    variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery
  • Variations of von Willebrand [ Time Frame: 48 hours ]
    variations in von Willebrand Concentration from 48 hours post surgery
Original Primary Outcome Measures
 (submitted: May 16, 2019)
  • Variations of CT-ROTEM [ Time Frame: 48 hours ]
    variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery
  • Variations of MCF-ROTEM [ Time Frame: 48 hours ]
    variations in maximum clotting firmness of ROTEM from baseline (preoperative) to 48 hours post surgery
  • Variations of PFA-100 [ Time Frame: 48 hours ]
    variations in COL-EPI (platelet function) from baseline (preoperative) to 48 hours post surgery
  • Variations of Factor XIII [ Time Frame: 48 hours ]
    variations in factor XIII clotting factor from baseline (preoperative) to 48 hours post surgery
  • Variations of von Willebrand [ Time Frame: 48 hours ]
    variations in von Willebrand from baseline (preoperative) to 48 hours post surgery
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2019)
Transfusion of red blood cells [ Time Frame: 20 days ]
number of packed red blood cells and percentage of transfused patients
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and HIPEC Intraperitoneal Chemotherapy (HIPEC)
Official Title Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
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.

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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Days
Biospecimen Not Provided
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)
Condition
  • Coagulation Disorder
  • Carcinomatosis
Intervention Diagnostic Test: ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII
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 Name: ROTEM, PFA-100
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 8, 2021)
46
Original Estimated Enrollment
 (submitted: May 16, 2019)
40
Actual Study Completion Date March 8, 2021
Actual Primary Completion Date March 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03956836
Other Study ID Numbers HUVirgenRocio
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Antonio M. Puppo Moreno, Hospitales Universitarios Virgen del Rocío
Study Sponsor Hospitales Universitarios Virgen del Rocío
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospitales Universitarios Virgen del Rocío
Verification Date March 2021