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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heparin, Perioperative

Intervention / Treatment
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* Drug: Heparin
* Drug: Heparin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin with a concentration of 2 U/ml<br>heparin dilution is placed in a pressure bag with a pressure of 300 mmHg | Drug: Heparin<br>* heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube<br>|
| Experimental: Heparin with a concentration of 4 U/ml<br>heparin dilution is placed in a pressure bag with a pressure of 300 mmHg | Drug: Heparin<br>* heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube<br>|
| Placebo Comparator: normal saline<br>normal saline is placed in a pressure bag with a pressure of 300 mmHg | Drug: normal saline<br>* normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube<br>|

What is the study measuring?
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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 |