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

Primary Purpose

Heparin, Perioperative

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Heparin

normal saline

About this trial

This is an interventional prevention trial for Heparin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Heparin with a concentration of 2 U/ml

Heparin with a concentration of 4 U/ml

normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The level of glass bead Clot Rate

10 min after the vein puncture, 2 h after skin incision and at the end of surgery

The level of glass bead Platelet Function

10 min after the vein puncture, 2 h after skin incision and at the end of surgery

The level of platelet count

24 h after surgery and 48 h after surgery

The frequencies of hand positional changes and manual artery flushing

The amount of infusion volume, blood loss, urine volume

The appearance of local complications of arterial puncture

Yes or No

Full Information

NCT ID

NCT04355273

First Posted

April 17, 2020

Last Updated

April 17, 2020

Sponsor

Yangzhou University

1. Study Identification

Unique Protocol Identification Number

NCT04355273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 24, 2018 (Actual)

Primary Completion Date

February 1, 2018 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heparin, Perioperative

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heparin with a concentration of 2 U/ml

Arm Type

Experimental

Arm Description

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

Arm Title

Heparin with a concentration of 4 U/ml

Arm Type

Experimental

Arm Description

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

Arm Title

normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Heparin

Intervention Description

heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube

Intervention Type

Drug

Intervention Name(s)

normal saline

Intervention Description

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

Primary Outcome Measure Information:

Title

The level of glass bead Activated Clotting Time

Description

10 min after the vein puncture, 2 h after skin incision and at the end of surgery

Time Frame

through study completion, an average of 3 minute

Secondary Outcome Measure Information:

Title

The level of glass bead Clot Rate

Description

10 min after the vein puncture, 2 h after skin incision and at the end of surgery

Time Frame

through study completion, an average of 3 minute

Title

The level of glass bead Platelet Function

Description

10 min after the vein puncture, 2 h after skin incision and at the end of surgery

Time Frame

through study completion, an average of 3 minute

Title

The level of platelet count

Description

24 h after surgery and 48 h after surgery

Time Frame

through study completion, an average of 2 minute

Title

The frequencies of hand positional changes and manual artery flushing

Time Frame

intraoperative

Title

The amount of infusion volume, blood loss, urine volume

Time Frame

intraoperative

Title

The appearance of local complications of arterial puncture

Description

Yes or No

Time Frame

within 24 h after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

the Affiliated Hospital of Yangzhou University, Yangzhou University

City

Yangzhou

State/Province

Jiangsu

ZIP/Postal Code

225012

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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