Individualized ANH for Non-cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
In this trial, we proposed an individualized acute normovolemic hemodilution (ANH), and conduct a randomized controlled trial to testify the effect of individualized ANH on red cells requirement for non-cardiac surgeries with anticipating major blood loss in adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective non-cardiac surgery with an anticipated red blood cells transfusion >8 units (or 1600ml)
Aged 18~75 years
Preoperative Hb level > 120g/L for men and > 110g/L for women.
Disqualifiers
Refusal of blood transfusion
Cardiopulmonary insufficiency
Cerebrovascular disease
Renal impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized ANH
Procedure/SurgeryParticipants will undergo individualized ANH based on the West China Liu's Score after anesthetic induction. The decision of autologous blood transfusion or allogeneic red cell transfusion will be made according to the West China Liu's Score.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ANH groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
ABT requirement
The perioperative allogeneic red blood cells consumption (Units per person).
Time frame
Up to 12 weeks.Secondary outcomes
1
Proportion of transfused participants
The proportion of participants receiving allogeneic red blood cells.
Time frame
Up to 12 weeks.2
Composite of in-hospital complications
The complications will be divided into five grades. Grade Ⅰ, recovery after temporary treatment, e.g., postoperative nausea and vomiting. Grade Ⅱ, prolonged hospitalization, e.g., infection requiring antibiotics treatment. Grade Ⅲ, life threatening complications requiring intense treatment during hospitalization, e.g., postoperative bleeding requiring re-operation, or acute renal insufficiency requiring dialysis therapy. Grade Ⅳ, life threatening complications resulting in significantly decreased quality of life, e.g., myocardial infarction. Grade Ⅴ, all-cause mortality during hospitalization.
Time frame
Up to 12 weeks.3
Length of hospital stay
The time from the day of admission to discharge from the hospital (Unit: days).
Time frame
Up to 12 weeks.4
Postoperative hospital stay
The time from the day of surgery to discharge from the hospital (Unit: days).
Time frame
Up to 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov