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: Acute Normovolemic Hemodilution, Bone Tumor, Goal-Directed Fluid Therapy, Transfusion. 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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Official title
The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
Overview
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Detailed description
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume 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. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer 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
- Intraoperative allogeneic red blood cell transfusion volume [Time frame: From the beginning to the end of the surgery]
Secondary outcome measures (9)
- 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]
- The intraoperative hemodynamic indexes [Time frame: From the beginning to the end of the surgery]
- 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]
- Length of stay in hospital [Time frame: Through study completion, an average of 1 year]
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: NCT06459141 · 2024-0156