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

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT04355273

Collaborator

(none)

Enrollment

Location

Arms

22.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heparin Perioperative	Drug: Heparin Drug: Heparin Drug: normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 24, 2018

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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
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 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

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

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 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

Outcome Measures

Primary Outcome Measures

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

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 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 amount of infusion volume, blood loss, urine volume [intraoperative]
The appearance of local complications of arterial puncture [within 24 h after surgery]
Yes or No

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China	225012

Sponsors and Collaborators

Yangzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhuan Zhang, Director, Yangzhou University

ClinicalTrials.gov Identifier:

NCT04355273

Other Study ID Numbers:

20200420

First Posted:

Apr 21, 2020

Last Update Posted:

Apr 21, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Flushing

Heparin

Calcium heparin

Study Results

No Results Posted as of Apr 21, 2020