Health TrialsbyHealthPanel

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

ConditionsBone TumorAcute Normovolemic HemodilutionGoal-Directed Fluid Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

age 18 to 75 years;

undergoing elective bone tumor resection surgery;

preoperative hemoglobin ≥11 g/dL;

Disqualifiers

using a tourniquet;

palliative operation or minimally invasive surgery;

BMI<18.5 or >30Kg/m²;

international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;

Trial design

Design model

Parallel

Treatments tested in this trial

  • acute normovolemic hemodilution

    Procedure/Surgery

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: acute normovolemic hemodilution group (ANH group)Experimental treatment 1 intervention
Group B: Standard Group (STD group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hemoglobin concentration on the first day after surgery

The concentration of hemoglobin on the first day after surgery

Time frame
The first day after surgery

Secondary outcomes

1

The rate of perioperative transfusion of allogeneic blood products

This includes blood products such as plasma and platelets, erythrocytes

Time frame
From the start of surgery to discharge or the 7th day following the operation, which comes first
2

The blood loss during the perioperative period

The volume of blood loss

Time frame
From the start of surgery to discharge or the 7th day following the operation, which comes first
3

The volume of fluid administration during the intraoperative period

This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume

Time frame
From the beginning to the end of the surgery
4

The coagulation function tests during the perioperative period

This includes thromboelastography result

Time frame
From the start of surgery to discharge or the 7th day following the operation, which comes first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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