Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The level of glass bead Activated Clotting Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Heparin with a concentration of 2 U/ml
heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
Intervention: Heparin (Drug)
Heparin with a concentration of 4 U/ml
heparin dilution is placed in a pressure bag with a pressure of 300 mmHg
Intervention: Heparin (Drug)
normal saline
normal saline is placed in a pressure bag with a pressure of 300 mmHg
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
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
- The amount of infusion volume, blood loss, urine volume(intraoperative)
- The level of glass bead Clot Rate(through study completion, an average of 3 minute)
- The level of glass bead Platelet Function(through study completion, an average of 3 minute)
- The level of platelet count(through study completion, an average of 2 minute)
- The frequencies of hand positional changes and manual artery flushing(intraoperative)
- The appearance of local complications of arterial puncture(within 24 h after surgery)
Investigators
Zhuan Zhang
Director
Yangzhou University