TourniquetsPhase 4NCT03229694
the Effect of Tracleer on Tourniquet-associated Hypertension
A Phase 4 study testing Tracleer 125Mg Tablet in people with Tourniquets and Hypertension, run by Xuzhou Medical University at 1 site in China.
Trial summary
Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. Thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourniquets, Hypertension, Bosentan
- What is being tested?
- Tracleer 125Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 May 2018
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent selected total knee arthroplasty under general anesthesia
- ASA II-III
- 18~65 years old
- Signed informed consent voluntarily
Who cannot join
- Do not apply tourniquet during the surgery
- Patients underwent emergency surgery
- Having applied tourniquet in last three months
- Patients underwent bilateral total knee arthroplasty
- Dysfunction of liver or kidney
- Anemia (Hb <90 g/L)
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- Serious myocardial disease (eg. coronary heart disease, heart failure, severe arrhythmia)
- Coagulation disorder
- Diabetic
- Leukocyte higher than normal value
- Pneumonia, asthma, chronic obstructive pulmonary disease
- Hypotension before surgery (systolic pressure < 90 mmHg)
- Pregnant woman or puerpera
- Having being enrolled in other clinical trial in last 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Jiang Cao, doctor, +86-516-85802291, xyfyll2297@163.com
About this study
Official title: Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. Thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery.
Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present trial, the investigators are going to investigate the effect of Tracleer on tourniquet-associated hypertension during total knee arthroplasty.
Read the detailed description
At present study, the investigators will use endothelin receptor antagonist, Tracleer (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The purpose of this study is to find a new therapy to prevent and treat tourniquet-associated hypertension.
- Conditions
- Tourniquets, Hypertension, Bosentan
- Being tested
- Tracleer 125Mg Tablet, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracleer 125Mg TabletDrug
Also called Bosentan, endothelin receptor antagonist
Tracleer was administered orally at two hours before surgery and six hours after surgery.
PlaceboDrug
Placebo was administered orally at two hour before surgery and six hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tracleer (or Bosentan) | Experimental | Tracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery Receives: Drug: Tracleer 125Mg Tablet |
| Placebo | Placebo comparator | Placebo was administered orally at two hours before surgery and six hours after surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum rate of change in systolic blood pressure (MR)
During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure
Measured: 24 hours after surgery
Secondary outcomes (2)
the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine
test the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine in plasma at different time point
Measured: baseline and intraoperative
visual analog scale
assess the efficacy of analgesia using visual analog scale (VAS)
Measured: 24 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Apr 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TourniquetsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Liu, Xuzhou Medical University
- Investigators
- Su Liu, doctor, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229694
- Sponsor's protocol ID
- XYFY-2017-068
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endothelin Receptor Blocker Tracleer on Toruniquet-associated Hypertension During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03229694
- Acronym / sponsor ID
- XYFY-2017-068
- Conditions
- Tourniquets, Hypertension, Bosentan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 25 Jul 2017 (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.
Tourniquet is widely used in orthopedic surgery. However, prolonged tourniquet inflation may cause a gradual rise in blood pressure, which named as tourniquet-associated hypertension. Thus, to effectively prevent the tourniquet related hemodynamic responses is important for patients receiving limb surgery.
Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension. Tracleer can also be used to treat retistant hypertension. At present trial, the investigators are going to investigate the effect of Tracleer on tourniquet-associated hypertension during total knee arthroplasty.
Detailed description
At present study, the investigators will use endothelin receptor antagonist, Tracleer (Bosentan), to investigate the effect of Tracleer on tourniquet-associated hypertension during unilateral total knee arthroplasty, and evaluate its safety and effectivity. The purpose of this study is to find a new therapy to prevent and treat tourniquet-associated hypertension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracleer (or Bosentan) | Experimental | Drug: Tracleer 125Mg TabletTracleer (Tracleer 125Mg Tablet) was administered orally at two hours before surgery and six hours after surgery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered orally at two hours before surgery and six hours after surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients underwent selected total knee arthroplasty under general anesthesia
- ASA II-III
- 18~65 years old
- Signed informed consent voluntarily
Key exclusion criteria (14 listed)
- Do not apply tourniquet during the surgery
- Patients underwent emergency surgery
- Having applied tourniquet in last three months
- Patients underwent bilateral total knee arthroplasty
- Dysfunction of liver or kidney
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 |
|---|---|---|
| Tracleer 125Mg TabletAlso: Bosentan, endothelin receptor antagonistTracleer was administered orally at two hours before surgery and six hours after surgery. | Drug | Tracleer (or Bosentan) |
| PlaceboPlacebo was administered orally at two hour before surgery and six hours after surgery. | Drug | Placebo |
Primary outcome
Maximum rate of change in systolic blood pressure (MR)
Time frame: 24 hours after surgery
During the observation, MR=(the highest value of systolic blood pressure - the baseline of systolic pressure ) / the baseline of systolic pressure
2 secondary outcomes
the concentration of endothelin-1, 5-hydroxytrypatamine, and norepinephrine
Time frame: baseline and intraoperative
visual analog scale
Time frame: 24 hrs after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Tourniquets
Enrolling by invitation
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
Local Epinephrine in Myomectomy
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Not yet recruiting
Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
Not yet recruiting
Effect of Tourniquet Use on the Pivot Shift Test
Anterior Cruciate Ligament Injury
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.
Su Liu, doctor principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tracleer 125Mg Tablet in people with Tourniquets and Hypertension, run by Xuzhou Medical 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 25 Jul 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Cao, professor (+86-516-85802291, xyfyll2297@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum rate of change in systolic blood pressure (MR) (time frame: 24 hours after surgery). 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 25 Jul 2017.