A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: acute normovolemic hemodilution.
- Who it may be relevant to
- Registry conditions: Bone Tumor, Acute Normovolemic Hemodilution, Goal-Directed Fluid Therapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.
Detailed description
Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor surgery.
Interventions
- Procedure acute normovolemic hemodilution
The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous
Primary outcome measures
- Hemoglobin concentration on the first day after surgery [Time frame: The first day after surgery]
Secondary outcome measures (7)
- The rate of perioperative transfusion of allogeneic blood products [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- The blood loss during the perioperative period [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- The volume of fluid administration during the intraoperative period [Time frame: From the beginning to the end of the surgery]
- The coagulation function tests during the perioperative period [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Perioperative embolic events [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Perioperative pulmonary infection [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Perioperative wound infection [Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first]
Eligibility criteria
Inclusion criteria
- age 18 to 75 years;
- undergoing elective bone tumor resection surgery;
- preoperative hemoglobin ≥11 g/dL;
Exclusion criteria
- using a tourniquet;
- palliative operation or minimally invasive surgery;
- BMI<18.5 or >30Kg/m\^2;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10\^9/L;
- cardiopulmonary insufficiency;
- hepatic and renal dysfunction;
- active infectious disease;
- allergy to succinyl gelatin;
- pregnancy;
- declined participation in the study or declined blood transfusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou
Identifiers
NCT: NCT06881498 · 2024 0584