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Trial Title:
The Effect of Hemodilution on Intraoperative Allogeneic Transfusion (HEAL)
NCT ID:
NCT06459141
Condition:
Acute Normovolemic Hemodilution
Bone Tumor
Goal-Directed Fluid Therapy
Transfusion
Conditions: Official terms:
Bone Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
acute normovolemic hemodilution
Description:
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.
Arm group label:
acute normovolemic hemodilution group (ANH group)
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.
Detailed description:
Bone tumor surgery is associated with a significant risk of perioperative 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, and
intraoperative fluid administration strategy is an important confounding factor. As
goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of
great importance to explore the efficacy of ANH in patients undergoing fluid management
using GDFT.
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, 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 when applying GDFT in patients undergoing bone tumor surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. age 18 to 75 years;
2. undergoing elective bone tumor resection surgery;
3. preoperative hemoglobin ≥11 g/dL;
Exclusion Criteria:
1. using a tourniquet;
2. palliative operation or minimally invasive surgery;
3. BMI<18.5 or >30Kg/m^2;
4. international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
5. cardiopulmonary insufficiency;
6. hepatic and renal dysfunction;
7. active infectious disease;
8. allergy to succinyl gelatin;
9. pregnancy;
10. declined participation in the study or declined blood transfusion
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Min Yan, Doctor
Phone:
15888210247
Email:
zryanmin@zju.edu.cn
Investigator:
Last name:
Min Yan, Doctor
Email:
Principal Investigator
Start date:
June 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06459141
