Effect of blood volume management during bone tumor surgery
The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
This study is testing if a method called acute normovolemic hemodilution can help reduce the need for blood transfusions during bone tumor surgeries for patients aged 18 to 75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06459141 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of acute normovolemic hemodilution (ANH) on reducing the need for blood transfusions during bone tumor surgeries. It aims to determine if ANH, when combined with goal-directed fluid therapy, can minimize intraoperative allogeneic red blood cell transfusions, which are associated with increased postoperative complications. The study will involve patients aged 18 to 75 undergoing elective bone tumor resection, assessing blood loss and transfusion requirements. By evaluating the efficacy of ANH in this context, the trial seeks to improve patient outcomes and reduce the risks associated with blood transfusions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are scheduled for elective bone tumor resection surgery with a preoperative hemoglobin level of at least 11 g/dL.
Not a fit: Patients with conditions such as cardiopulmonary insufficiency, hepatic and renal dysfunction, or those undergoing palliative operations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions and improve recovery outcomes for patients undergoing bone tumor surgery.
How similar studies have performed: While the efficacy of acute normovolemic hemodilution has been controversial, this study aims to clarify its role in a specific surgical context, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.