The Effect of Hemodilution on Intraoperative Allogeneic Transfusion (HEAL)

Transfusion Clinical Trial

Official title:

The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459141
• Other study ID #: 2024-0156
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Normovolemic Hemodilution
• Bone Neoplasms
• Bone Tumor
• Goal-Directed Fluid Therapy
• Transfusion

Intervention

Procedure:
• acute 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The blood loss during the perioperative period	The volume of blood loss	From the start of surgery to discharge or the 7th day following the operation, which comes first
Secondary	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
Secondary	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
Secondary	The intraoperative hemodynamic indexes	This includes stroke volume variation	From the beginning to the end of the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay in hospital		Through study completion, an average of 1 year