Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer

NCT ID: NCT04355273

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2019-12-01

Brief Summary

Heparin diluent or normal saline is generally used as the arterial tube flushing in clinical practice, but there is no consensus on the choice of flushing fluid. Heparin can affect the blood coagulation function, and even lead to heparin-related thrombocytopenia, increasing the risk of perioperative embolism. Sonoclot is a blood viscoelasticity test, which can provide comprehensive information on the coagulation's cascade and the entire process and be quicker and more effective than routine laboratory coagulation tests. In this research, the coagulation and platelet function analyzer called Sonoclot is used to evaluate the effect of different concentrations of pressurized heparin on the coagulation and platelet function of perioperative patients, which can provide a reference for the clinical choice of appropriate arterial flushing.

Conditions

Heparin; Perioperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Heparin with a concentration of 2 U/ml

heparin dilution is placed in a pressure bag with a pressure of 300 mmHg

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Heparin with a concentration of 4 U/ml

heparin dilution is placed in a pressure bag with a pressure of 300 mmHg

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

normal saline

normal saline is placed in a pressure bag with a pressure of 300 mmHg

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Interventions

Heparin

heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Intervention Type: DRUG

Heparin

heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Intervention Type: DRUG

normal saline

normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of gastrointestinal cancer
• Ages ranged from 18 to 75
• ASA I~III

Exclusion Criteria

• Pregnancy
• modified Allen Test negative
• history of taking anti-platelet drugs such as aspirin one week before surgery, heparin allergy and thrombotherapy
• two failed catheterizations of the same artery
• significant diseases in liver and kidney function
• refusal of patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20200420

Identifier Type: -

Identifier Source: org_study_id