The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/SurgeryThe 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
150 Participants
are divided into 2 treatment groupsGroup 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
Intraoperative allogeneic red blood cell transfusion volume
The volume of allogeneic red blood cell transfusions during the intraoperative period. Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.
Time frame
From the beginning to the end of the surgerySecondary 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 first2
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 first3
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 surgery4
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 firstSponsors and contacts
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Source ClinicalTrials.gov