Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the… (NCT06255366) | Clinical Trial Compass
UnknownPhase 4
Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion
126 participantsStarted 2024-03-28
Plain-language summary
To study the clinical efficacy of carosodiumsulfonate and desmopressin in improving the clarity of vision under endoscope, perioperative bleeding volume and anti-inflammatory effect in endoscopic lumbar fusion
Who can participate
Age range
35 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, aged 35-65 years old, who were diagnosed as single-segment lumbar spondylolisthesis without spondylolysis based on imaging data and underwent endoscopic lumbar interbody fusion.
. In patients with normal platelet count, blood coagulation function.
. No history of major lumbar trauma and previous lumbar surgery.
. No allergy history, contraindications and serious adverse reactions to desmopressin and carosodiumsulfonate.
. American Society of Anesthesiologists (ASA) classification: grade 1-2
. The participants and their family members were informed of the nature of the study, understood the provisions of the study, complied well, and signed informed consent
Exclusion criteria
. Patients who do not consent to participate in the trial.
. Poorly controlled hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg.
. People with mental illness, or poor compliance of patients.
. Patients with severe liver function impairment and creatinine clearance \<20ml/min.
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
Clarity under microscope
Timeframe: During the operation
2
Total Blood Loss（TBL）
Timeframe: During the operation
3
Intraoperative Blood Loss（IBL）
Timeframe: During the operation
4
Hidden Blood Loss（HBL）
Timeframe: During the operation
5
Duration of surgery
Timeframe: During the operation
6
Intraoperative perfusion fluid consumption
Timeframe: During the operation
7
Red blood cells were counted in the postoperative drainage fluid
Timeframe: Up to 72 hours after surgery
8
Intraoperative blood pressure values
Trial details
NCT IDNCT06255366
SponsorChengdu University of Traditional Chinese Medicine