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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04355273
Enrollment
60
Registered
2020-04-21
Start date
2018-01-24
Completion date
2019-12-01
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin, Perioperative

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.

Interventions

DRUGHeparin

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

DRUGnormal saline

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

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The level of glass bead Activated Clotting Timethrough study completion, an average of 3 minute10 min after the vein puncture, 2 h after skin incision and at the end of surgery

Secondary

MeasureTime frameDescription
The level of glass bead Platelet Functionthrough study completion, an average of 3 minute10 min after the vein puncture, 2 h after skin incision and at the end of surgery
The level of platelet countthrough study completion, an average of 2 minute24 h after surgery and 48 h after surgery
The level of glass bead Clot Ratethrough study completion, an average of 3 minute10 min after the vein puncture, 2 h after skin incision and at the end of surgery
The amount of infusion volume, blood loss, urine volumeintraoperative
The appearance of local complications of arterial puncturewithin 24 h after surgeryYes or No
The frequencies of hand positional changes and manual artery flushingintraoperative

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026