Effect of Blood Management in Bone Tumor Surgery
A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06881498
This study is testing if a blood management technique called acute normovolemic hemodilution can help people having bone tumor surgery avoid anemia and its complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06881498 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of acute normovolemic hemodilution (ANH) on postoperative hemoglobin levels in patients undergoing elective bone tumor resection surgery. It aims to determine if ANH, when combined with goal-directed fluid therapy (GDFT), can reduce the risk of perioperative anemia and its associated complications. The trial is designed as a randomized, controlled trial to provide robust data on the efficacy of this blood management strategy in a high-risk surgical setting.
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 who are undergoing palliative operations, have significant comorbidities, or are outside the specified age and hemoglobin criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve long-term outcomes for patients undergoing bone tumor surgery.
How similar studies have performed: While the efficacy of acute normovolemic hemodilution has been debated, this study's focus on its application within goal-directed fluid therapy is a novel approach that has not been extensively tested.
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.
Conditions: Bone Tumor, Acute Normovolemic Hemodilution, Goal-Directed Fluid Therapy