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

NCT04355273 | Completed

• 1 other identifier: 20200420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The level of glass bead Clot Rate

  through study completion, an average of 3 minute

• The level of glass bead Platelet Function

  through study completion, an average of 3 minute

• The level of platelet count

  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

Study Arms (3)

Heparin with a concentration of 2 U/ml

EXPERIMENTAL

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

Drug: Heparin

Heparin with a concentration of 4 U/ml

EXPERIMENTAL

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

Drug: Heparin

normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Heparin 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 2 U/ml

normal saline DRUG

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

normal saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

MeSH Terms

Interventions

Heparin; Saline Solution

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: January 24, 2018
• Primary Completion: February 1, 2018
• Study Completion: December 1, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

CN (1)