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The stepwise strategy for goal-directed perioperative red blood cell transfusion based on regional cerebral oxygen saturation in elderly patients with hip fractures

The stepwise strategy for goal-directed perioperative red blood cell transfusion based on regional cerebral oxygen saturation in elderly patients with hip fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109173
Enrollment
Unknown
Registered
2025-09-14
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture

Interventions

10-gram group:No intervention
Control Group 1 (regional cerebral oxygen saturation =55%) showed a decrease of less than 5% compared to baseline:No red blood cell transfusion
Control Group 2 (regional cerebral oxygen saturation =55%) showed a decrease of more than 5% compared to baseline:Red blood cell transfusion

Sponsors

The First Affiliated Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients who may require allogeneic red blood cell suspension transfusion during surgery and within 72 hours postoperatively, and whose hemoglobin (Hb) level is below 10 g/dL (if autologous blood reinfusion is used perioperatively, then whose Hb remains below 10 g/dL after the complete reinfusion of autologous blood), will be formally enrolled and randomized into the study. If a patient experiences acute blood loss necessitating transfusion consideration while undergoing autologous blood reinfusion, they will also be enrolled if their Hb level is below 10 g/dL after the autologous blood reinfusion at that time point. Eligible patients will be assigned to groups according to their randomization number. Patients will be allocated into three groups in a 1:1:1 ratio, using randomization to balance the treatment groups. (A permuted block randomization with variable block size, 1:1:1 ratio, stratified by gender and fracture site (femoral neck, intertrochanteric, or subtrochanteric fracture), will be performed centrally through a data management system.)

Exclusion criteria

Exclusion criteria: Patients with hematological diseases, impaired hemoglobin oxygen-carrying capacity (such as methemoglobinemia), acute coronary syndrome (ACS), cardiopulmonary insufficiency, renal insufficiency, and multiple tumors and/or tumor metastases.

Design outcomes

Primary

MeasureTime frame
Transfusion rate and transfusion volume;All-cause mortality rate within 60 days in patients;

Secondary

MeasureTime frame
ICU admission rate and ICU length of stay;?Postoperative hemoglobin recovery;Drain removal time;Surgical incision healing status;Incidence of major complications;Length of hospital stay and hospitalization costs;

Countries

China

Contacts

Public Contacthuangchangshun

The First Affiliated Hospital of Ningbo University

nbhcs1967@163.com+86 139 5788 2779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026