RecruitingNot ApplicableNCT06459141

The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

150 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Transfusion Bone Tumor Acute Normovolemic Hemodilution Goal-Directed Fluid Therapy

Summary

The prevention of intraoperative allogenetic blood transfusion 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 reduce the volume of intraoperative allogeneic red blood cell transfusion when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

age 18 to 75 years;
undergoing elective bone tumor resection surgery;
preoperative hemoglobin ≥11 g/dL;

Exclusion Criteria10

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

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Interventions

PROCEDUREacute 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 catheter to maintain hemodynamic stability.