Actively Recruiting
A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-15
32
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Bone tumor surgery often leads to significant blood loss, which can cause postoperative anemia and increase the risk of complications and affect long-term survival. Researchers are evaluating the effect of acute normovolemic hemodilution (ANH) combined with goal-directed fluid therapy (GDFT) in patients undergoing bone tumor surgery. This study aims to determine if ANH can improve hemoglobin levels after surgery, addressing previous uncertainties about ANH's clinical benefits when fluid management is carefully controlled. Participants are randomly assigned to one of two groups. In the ANH group, blood is drawn after anesthesia and replaced with a fluid to maintain blood volume, followed by GDFT during surgery. In the standard care group, only GDFT is applied throughout the surgery without ANH. The trial carefully monitors fluid management strategies to assess the impact of ANH on patient outcomes. Throughout the study, participants will have their hemoglobin levels measured on the first day after surgery as the primary outcome. Secondary measures include blood loss, blood transfusion rates, fluid volume during surgery, coagulation tests, and infections up to seven days post-surgery. The study includes preoperative assessments, intraoperative monitoring, and postoperative follow-up to evaluate safety and efficacy over the hospital stay period.
CONDITIONS
Brief Title
A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Undergoing elective bone tumor resection surgery
- Preoperative hemoglobin level of at least 11 g/dL
You will not qualify if you...
- Use of a tourniquet during surgery
- Palliative or minimally invasive surgery
- Body mass index (BMI) less than 18.5 or greater than 30 kg/m²
- International normalized ratio (INR) greater than 1.5 or platelet count below 100 × 10⁹/L
- Cardiopulmonary insufficiency
- Liver or kidney dysfunction
- Active infectious disease
- Allergy to succinyl gelatin
- Pregnancy
- Declined participation in the study or blood transfusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo bone tumor surgery with either acute normovolemic hemodilution and goal-directed fluid therapy or goal-directed fluid therapy alone. The surgical procedure involves significant blood loss and fluid management.
1 visit (in-person)
Duration - Up to 7 days after surgery or until discharge, whichever comes first
Participants are monitored for post-operative hemoglobin levels, transfusion needs, blood loss, coagulation function, and potential complications such as embolic events and infections.
Daily visits or assessments during hospital stay
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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