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.
Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss 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. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
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.
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, China
RECRUITINGHemoglobin concentration on the first day after surgery
The concentration of hemoglobin on the first day after surgery
Time frame: The first day after surgery
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
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
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
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
Perioperative embolic events
This includes thrombosis and embolism
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative pulmonary infection
Diagnose according to radiologic examination, sign and symptom
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Perioperative wound infection
Diagnose according to sign, symptom
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
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