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Completed

NCT Number: NCT04355273

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.

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Key information

Conditions

Heparin periOperative

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, 225012, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin

Drug

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

normal saline

Drug

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

Primary outcomes

  1. The level of glass bead Activated Clotting Time

    Time frame: 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 outcomes

  1. The level of glass bead Clot Rate

    Time frame: 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

  2. The level of glass bead Platelet Function

    Time frame: 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

  3. The level of platelet count

    Time frame: through study completion, an average of 2 minute

    24 h after surgery and 48 h after surgery

  4. The frequencies of hand positional changes and manual artery flushing

    Time frame: intraoperative

  5. The amount of infusion volume, blood loss, urine volume

    Time frame: intraoperative

  6. The appearance of local complications of arterial puncture

    Time frame: within 24 h after surgery

    Yes or No

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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