HeparinNCT04355273
Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer
A study testing Heparin and normal saline in people with Heparin and Perioperative, run by Yangzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heparin, Perioperative
- What is being tested?
- Heparin and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of gastrointestinal cancer
- Ages ranged from 18 to 75
- ASA I~III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012
About this study
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.
- Conditions
- Heparin, Perioperative
- Being tested
- Heparin, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
HeparinDrug
heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
normal salineDrug
normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
| Study group | Role | What they receive |
|---|---|---|
| Heparin with a concentration of 2 U/ml | Experimental | heparin dilution is placed in a pressure bag with a pressure of 300 mmHg Receives: Drug: Heparin |
| Heparin with a concentration of 4 U/ml | Experimental | heparin dilution is placed in a pressure bag with a pressure of 300 mmHg Receives: Drug: Heparin |
| normal saline | Placebo comparator | normal saline is placed in a pressure bag with a pressure of 300 mmHg Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 3 minute
Secondary outcomes (6)
The level of glass bead Clot Rate
10 min after the vein puncture, 2 h after skin incision and at the end of surgery
Measured: 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
Measured: through study completion, an average of 3 minute
The level of platelet count
24 h after surgery and 48 h after surgery
Measured: through study completion, an average of 2 minute
The frequencies of hand positional changes and manual artery flushing
Measured: intraoperative
The amount of infusion volume, blood loss, urine volume
Measured: intraoperative
The appearance of local complications of arterial puncture
Yes or No
Measured: within 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start24 Jan 2018
- Primary completion1 Feb 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeparinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355273
- Sponsor's protocol ID
- 20200420
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer
- ClinicalTrials.gov ID
- NCT04355273
- Acronym / sponsor ID
- 20200420
- Conditions
- Heparin, Perioperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heparin with a concentration of 2 U/ml | Experimental | Drug: Heparinheparin dilution is placed in a pressure bag with a pressure of 300 mmHg |
| Heparin with a concentration of 4 U/ml | Experimental | Drug: Heparinheparin dilution is placed in a pressure bag with a pressure of 300 mmHg |
| normal saline | Placebo comparator | Drug: normal salinenormal saline is placed in a pressure bag with a pressure of 300 mmHg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of gastrointestinal cancer
- Ages ranged from 18 to 75
- ASA I~III
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparinheparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube | Drug | Heparin with a concentration of 2 U/ml |
| Heparinheparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube | Drug | Heparin with a concentration of 4 U/ml |
| normal salinenormal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube | Drug | normal saline |
Primary outcome
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
6 secondary outcomes
The level of glass bead Clot Rate
Time frame: through study completion, an average of 3 minute
The level of glass bead Platelet Function
Time frame: through study completion, an average of 3 minute
The level of platelet count
Time frame: through study completion, an average of 2 minute
The frequencies of hand positional changes and manual artery flushing
Time frame: intraoperative
The amount of infusion volume, blood loss, urine volume
Time frame: intraoperative
The appearance of local complications of arterial puncture
Time frame: within 24 h after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin and normal saline in people with Heparin and Perioperative, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of glass bead Activated Clotting Time (time frame: through study completion, an average of 3 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.