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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute normovolemic hemodilution group (ANH group) | Experimental | The ANH process was initiated after tracheal intubation. After completion of ANH, goal-directed fluid therapy will begin until the end of the surgery. |
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| Standard Group (STD group) | No Intervention | After tracheal intubation, goal-directed fluid therapy will be implemented until the end of the surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acute normovolemic hemodilution | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin concentration on the first day after surgery | The concentration of hemoglobin on the first day after surgery | The first day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of perioperative transfusion of allogeneic blood products | This includes blood products such as plasma and platelets, erythrocytes | From the start of surgery to discharge or the 7th day following the operation, which comes first |
| The blood loss during the perioperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University anesthesiology department | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
The volume of blood loss |
| 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 | From the beginning to the end of the surgery |
| The coagulation function tests during the perioperative period | This includes thromboelastography result | 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 | 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 | 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 | From the start of surgery to discharge or the 7th day following the operation, which comes first |