Clinical Trials Logo
  1. Home
  2. Carcinomatosis
  3. NCT03956836

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

Coagulation Disorder Clinical Trial

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

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03956836
Study type Observational [Patient Registry]
Source Hospitales Universitarios Virgen del Rocío
Contact
Status Completed
Phase
Start date March 27, 2020
Completion date March 8, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Recruiting NCT03136510 - Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban N/A
Completed NCT01588132 - Anfibatide Phase 1 Clinical Trial in Healthy Volunteers Phase 1
Recruiting NCT04488341 - Effect of Aerobic Exercises on Sex Hormones and Coagulation Factors in Postmenopausal Elderly Women N/A
Recruiting NCT04524637 - The Utility of Thromboelastography in Traumatic Brain Injury
Completed NCT03634215 - Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma
Completed NCT05152420 - Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects Phase 1
Recruiting NCT05645081 - Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
Completed NCT04322721 - Coagulopathy on the First Postoperative Day Predicts the Long-term Survival of Traumatic Brain Injury Patients
Completed NCT03267823 - INR Comparison Testing in Cardiac Surgery
Completed NCT04490759 - QStat Pilot Reference Range Study
Completed NCT04107818 - Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
Recruiting NCT05484830 - Coagulation in Acute Aortic Dissection N/A
Recruiting NCT04111120 - Heparin Like Effect in Acute Variceal Bleeding
Completed NCT05162339 - Inflammatory Bowel Disease and Thromboembolic Events
Completed NCT03555630 - Thromboelastogram in Postdelivery Preeclamptic Patients
Completed NCT01589172 - Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury
Recruiting NCT04278404 - Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Completed NCT06154018 - Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass. N/A