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

• Sponsor: Hospitales Universitarios Virgen del Rocío (Other)
• Overall Status: Completed
• CT.gov ID: NCT03956836
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Actual Duration (Months): 11.4
• Patients Per Site Per Month: 4

Study Details

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	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 46 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Perioperative Coagulopathy in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
• Actual Study Start Date: Mar 27, 2020
• Actual Primary Completion Date: Mar 8, 2021
• Actual Study Completion Date: Mar 8, 2021

Outcome Measures

Primary Outcome Measures

1. Variations of CT-ROTEM [48 hours]

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

2. Variations of MCF-ROTEM [48 hours]

   variations in maximum clotting firmness of ROTEM 48 hours post surgery

3. Variations of PFA-100 [48 hours]

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

4. Variations of Factor XIII [48 hours]

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

5. Variations of von Willebrand [48 hours]

   variations in von Willebrand Concentration from 48 hours post surgery

Secondary Outcome Measures

1. Transfusion of red blood cells [20 days]

   number of packed red blood cells and percentage of transfused patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia	Spain	41012

Sponsors and Collaborators

• Hospitales Universitarios Virgen del Rocío

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio M. Puppo Moreno, Critical Care Staff, Hospitales Universitarios Virgen del Rocío
• ClinicalTrials.gov Identifier: NCT03956836
• Other Study ID Numbers: HUVirgenRocio
• First Posted: May 21, 2019
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Mar 9, 2021