Hypovolemia, acute normovolemic hemodilution (ANH)
Conditions
Interventions
Experimental group:The ANH operation in this study was to collect autologous blood first, and stop blood collection when the volume of blood collection reached the pre-set standard, at this time the b
Control group:The ANH operation in this study was to collect autologous blood first, and stop blood collection when the volume of blood collection reached the pre-set standard, at this time the body's
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age is 18~65 years old, gender is not limited (including boundary value); (2) Weight not less than 50 kg for males, not less than 45 kg for females, not more than 100 kg, and body mass index [BMI = weight (kg)/height2(m2)] within the range of 19.0~30.0 kg/m2 (including borderline values); (3) Elective surgery is planned and the expected duration of surgery is less than 6h; (4) Anticipated ANH blood collection of 10% to 15% of the total blood volume; (5) Hb >=110 g/L and Hct >=33%; (6) American Society of Anesthesiologists (ASA) rating ?~?; (7) Voluntary participation and written informed consent.
Exclusion criteria
Exclusion criteria: (1) Known hypersensitivity or allergy to starch and any component of the test drug; (2) Received anemia-related therapy, colloidal solutions, and/or blood products 14 days prior to surgery; (3) Hematologic disorders (e.g., sickle cell anemia, disorders of bead production anemia), excessive blood catecholamine levels (pheochromocytoma); (4) Suffering from severe cerebrovascular disease; (5) Those with pre-existing indications of aortic insufficiency of closure, aortic constriction, or severe peripheral vascular disease, which the investigator determines to be inappropriate for participation in this trial; (6) Hypertensive patients with poorly controlled blood pressure (SBP >=160 mmHg and/or DBP >=100 mmHg) and/or inability to discontinue medication such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor antagonists (ARBs) antihypertensive medications, or diuretics 10 hours prior to the procedure; (7) History of poorly controlled diabetes mellitus, which is judged by the investigator to be inappropriate for participation in this trial; (8) History of prior epilepsy and cerebral infarction (except for clinically insignificant lacunar cerebral infarction); (9) History of advanced malignancy (except non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ that has been cured and does not require follow-up); (10) Significant risk of bleeding or coagulation disorders that are assessed by the investigator to be unsuitable for surgery, including but not limited to: a) Previous/existing thrombosis or thromboembolic event, or increased risk of thrombosis or thromboembolic event; b) Requirement for antiplatelet or anticoagulant medications (e.g., warfarin, clopidogrel) other than acetylsalicylic acid (up to 100 mg/d); c) Prior history of gastrointestinal, intracerebral hemorrhage or other bleeding events considered severe, such as those caused by the use of nonsteroidal anti-inflammatory drugs; d) Prolonged PT > 3 seconds above the upper limit of normal or prolonged APTT > 10 seconds above the upper limit of normal and assessed by the investigator to be unsuitable for surgery; e) PLT 2x upper limit of normal value Albumin level 1.5 times upper limit of normal value (15) Those with abnormal renal function assessed at Screening and assessed by the Investigator to be unsuitable for surgery: Cr or BUN/Urea > 1.5 times the upper limit of normal values; (16) Presence of water-electrolyte disturbances during the Screening Period; (17) Presence of serious cardiac disease including, but not limited to, unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to Screening), myocardial infarction (within 6 months prior to Screening), New York Heart Association (NYHA) Classification >=III, congestive heart failure, severe arrhythmias poorly controlled by medications, n
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in beat-to-beat volume (SV) 5 min after completion of ANH compared with the immediate period before the start of ANH; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in inferior vena cava diameter (IVC) 5 min after completion of ANH compared with immediately before the start of ANH;Changes in cardiac output (CO), stroke volume variation per beat (SVV), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) 5 min after completion of ANH compared with the immediate period before the start of ANH;Changes in Hb and Hct 5 min after completion of ANH compared with the immediate period before the start of ANH;Fluid intake and output 5 min after completion of ANH compared with the immediate period before the start of ANH;Allogeneic blood (red blood cells, fresh frozen plasma, whole blood) transfusions from immediately prior to the start of ANH to 2h after the end of the procedure; | — |
Countries
China
Contacts
Public ContactFeng Yi
Peking University People's Hospital
Outcome results
None listed