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

Not Applicable

Completed

• Conditions: Perioperative; Heparin
• Interventions: Drug: Heparin; Drug: normal saline

• Registration Number: NCT04355273
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-24
• Primary Completion: 2018-02-01
• Study Completion: 2019-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin with a concentration of 2 U/ml	Heparin	heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
Heparin with a concentration of 4 U/ml	Heparin	heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
normal saline	normal saline	normal saline is placed in a pressure bag with a pressure of 300 mmHg

Primary Outcome Measures

Name	Time	Method
The level of glass bead Activated Clotting Time	through study completion, an average of 3 minute	10 min after the vein puncture, 2 h after skin incision and at the end of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China