Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

Postoperative Complications Clinical Trial

— CONTEST  

Official title:

Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04744688
• Other study ID #: 1-10-72-212-20
• Status: Not yet recruiting
• Start date: March 15, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2020
• Source: University of Aarhus
• Contact: Anne-Mette Hvas, MD, PhD
• Phone: +4523348252
• Email: annehvas[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cytoreductive surgery with HIPEC patients:

• Able to give informed consent
• Age = 18 years
• Diagnosed with peritoneal metastases from colorectal cancer
• Planned to undergo cytoreductive surgery with HIPEC

Minimally invasive rectal cancer patients:

• Able to give informed consent
• Age = 18 years
• Diagnosed with rectal cancer
• Planned to undergo minimal invasive rectal cancer resection with one of: total mesorectal excision, partial mesorectal excision or abdominoperineal excision

Exclusion Criteria (both groups):

• Thromboembolic event within 90 days before surgery
• Secondary malignancy within previous 5 years or concomitant, except non-melanoma skin cancer.

Related Conditions & MeSH terms

• Bleeding
• Carcinoma
• Coagulation
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Cytoreductive Surgery
• Intestinal Neoplasms
• Laparoscopic Surgery
• Laparoscopy
• Minimally Invasive Surgical Procedures
• Neoplasm Metastasis
• Neoplasms
• Peritoneal Carcinomatosis
• Peritoneal Metastases
• Peritoneal Neoplasms
• Postoperative Complications
• Surgical Oncology
• Surgical Procedures, Operative
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Denmark	Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between changes in concentration of prothrombin fragment 1+2.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in platelet concentration from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years
Secondary	The difference between changes in concentration of immature platelets from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years
Secondary	The difference between changes in concentration of plasma selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years
Secondary	The difference between changes in activated partial thromboplastin time "APTT" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in international normalized ratio "INR" (seconds) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of plasma fibrinogen from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of coagulation factor VIII from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of von wildebrand factor from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of thrombin-antithrombin complex from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in thrombin generation before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.; Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.; Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of plasminogen activator inhibitor-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of fibrin d-dimer from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in global hemostasis by Rotational thromboelastometry (ROTEM) from before surgery to the end of surgery (both groups)	The difference will be measured in blood samples from before surgery to the end of surgery (both groups).; ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of syndecan-1 from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of sE-selectin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of soluble thrombomodulin. from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of hemoglobin from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of leucocytes from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration C-reactive protein (CRP) from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.	The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of prothrombin fragment 1+2. from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in platelet concentration from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of immature platelets from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in activated partial thromboplastin time "aPTT" (seconds) from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in activated international normalized ratio "INR" (seconds) from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of plasma fibrinogen from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of coagulation factor VIII from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of von wildebrand factor from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of thrombin-antithrombin complex from the end of cytoreductive surgery to the end HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in thrombin generation from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM*min).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes of fibrin clot structure from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of plasminogen activator inhibitor-1 from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of fibrin d-dimer from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of global hemostasis measured by Rotational thromboelastometry (ROTEM) from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery to the end HIPEC.; ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of syndecan-1 from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of sE-selectin from the end of cytoreductive surgery to the end of HIPEC	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of soluble thrombomodulin from the end of cytoreductive surgery to the end of HIPEC	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of hemoglobin from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of leucocytes from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years.
Secondary	The difference between changes in concentration of C-reactive protein (CRP) from the end of cytoreductive surgery to the end of HIPEC.	The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.	Data will be analyzed, assessed, and presented within three years
Secondary	Incidence of deep vein thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing minimally invasive rectal cancer resection.	Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.	Data will be analyzed, assessed, and presented within three years
Secondary	Incidence of deep venous thrombosis measured by doppler ultrasonography in colorectal cancer patients undergoing cytoreductive surgery with HIPEC	Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.	Data will be analyzed, assessed, and presented within three years