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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.
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.
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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 |
|---|---|---|
| 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. | From the beginning to the end of the 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 |
| The intraoperative hemodynamic indexes | This includes stroke volume variation | From the beginning to the end of the surgery |
| 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, etc | From the start of surgery to discharge or the 7th day following the operation, which comes first |
| Length of stay in hospital | Through study completion, an average of 1 year |