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 range35 Years – 65 Years
SexALL
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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.
✕. Patients with coagulopathy or inability to tolerate surgery.
✕. Patients with other lumbar spine diseases or pulmonary tuberculosis.
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
Timeframe: During the operation
Trial details
NCT IDNCT06255366
SponsorChengdu University of Traditional Chinese Medicine