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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative; Heparin
• Intervention / Treatment: Drug: Heparin; Drug: Heparin; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225012
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Heparin with a concentration of 2 U/ml; heparin dilution is placed in a pressure bag with a pressure of 300 mmHg	Drug: Heparin; heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube; Drug: Heparin; heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
EXPERIMENTAL: Heparin with a concentration of 4 U/ml; heparin dilution is placed in a pressure bag with a pressure of 300 mmHg	Drug: Heparin; heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube; Drug: Heparin; heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
PLACEBO_COMPARATOR: normal saline; normal saline is placed in a pressure bag with a pressure of 300 mmHg	Drug: normal saline; normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The level of platelet count	24 h after surgery and 48 h after surgery	through study completion, an average of 2 minute
The frequencies of hand positional changes and manual artery flushing		intraoperative
The amount of infusion volume, blood loss, urine volume		intraoperative
The appearance of local complications of arterial puncture	Yes or No	within 24 h after surgery

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2018
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Flushing; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: 20200420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No