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

Coagulation Disorder Clinical Trial

— HIPEC-COAG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956836
• Other study ID #: HUVirgenRocio
• Status: Completed
• Start date: March 27, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2021
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Carcinoma
• Carcinomatosis
• Coagulation Disorder
• Hemostatic Disorders

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations of CT-ROTEM	variations in clotting time of ROTEM from baseline (preoperative) to 48 hours post surgery	48 hours
Primary	Variations of MCF-ROTEM	variations in maximum clotting firmness of ROTEM 48 hours post surgery	48 hours
Primary	Variations of PFA-100	variations in COL-EPI (platelet function) from of 48 hours post surgery	48 hours
Primary	Variations of Factor XIII	variations in factor XIII Concentration of clotting factor from baseline (preoperative) of 48 hours post surgery	48 hours
Primary	Variations of von Willebrand	variations in von Willebrand Concentration from 48 hours post surgery	48 hours
Secondary	Transfusion of red blood cells	number of packed red blood cells and percentage of transfused patients	20 days