Acute Normovolemic Hemodilution, Bone Tumor, Goal-Directed Fluid Therapy, Transfusion
Conditions
Brief summary
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.
Detailed description
Bone tumor surgery is associated with a significant risk of intraoperative 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. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients. Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, 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 in patients undergoing bone cancer surgery.
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative allogeneic red blood cell transfusion volume | From the beginning to the end of the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of perioperative transfusion of allogeneic blood products | From the start of surgery to discharge or the 7th day following the operation, which comes first | This includes blood products such as plasma and platelets, erythrocytes |
| The blood loss during the perioperative period | From the start of surgery to discharge or the 7th day following the operation, which comes first | The volume of blood loss |
| The volume of fluid administration during the intraoperative period | From the beginning to the end of the surgery | This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume |
| The coagulation function tests during the perioperative period | From the start of surgery to discharge or the 7th day following the operation, which comes first | This includes thromboelastography result |
| The intraoperative hemodynamic indexes | From the beginning to the end of the surgery | This includes stroke volume variation |
| Perioperative embolic events | From the start of surgery to discharge or the 7th day following the operation, which comes first | This includes thrombosis and embolism |
| Perioperative pulmonary infection | From the start of surgery to discharge or the 7th day following the operation, which comes first | Diagnose according to radiologic examination, sign and symptom |
| Perioperative wound infection | From the start of surgery to discharge or the 7th day following the operation, which comes first | Diagnose according to sign, symptom, etc |
| Length of stay in hospital | Through study completion, an average of 1 year | — |
Countries
China
Outcome results
None listed