RecruitingNot ApplicableNCT06881498

A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

32 participants

Start Date

Jun 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


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.


Locations(1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

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NCT06881498


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