the Effect of Tracleer on Tourniquet-associated Hypertension (NCT03229694) | Clinical Trial Compass
UnknownPhase 4
the Effect of Tracleer on Tourniquet-associated Hypertension
China80 participantsStarted 2017-08-01
Plain-language 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.
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients underwent selected total knee arthroplasty under general anesthesia
* ASA II-III
* 18\~65 years old
* Signed informed consent voluntarily
Exclusion Criteria:
* 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)
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum rate of change in systolic blood pressure (MR)