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

Heparin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355273
• Other study ID #: 20200420
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Heparin
• Perioperative

Intervention

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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of glass bead Activated Clotting Time	10 min after the vein puncture, 2 h after skin incision and at the end of surgery	through study completion, an average of 3 minute
Secondary	The level of glass bead Clot Rate	10 min after the vein puncture, 2 h after skin incision and at the end of surgery	through study completion, an average of 3 minute
Secondary	The level of glass bead Platelet Function	10 min after the vein puncture, 2 h after skin incision and at the end of surgery	through study completion, an average of 3 minute
Secondary	The level of platelet count	24 h after surgery and 48 h after surgery	through study completion, an average of 2 minute
Secondary	The frequencies of hand positional changes and manual artery flushing		intraoperative
Secondary	The amount of infusion volume, blood loss, urine volume		intraoperative
Secondary	The appearance of local complications of arterial puncture	Yes or No	within 24 h after surgery