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
Heparin
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Heparin
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
Sites / Locations
- the Affiliated Hospital of Yangzhou University, Yangzhou University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
We'll reach out to this number within 24 hrs