Effect of Indication Based Blood Product Transfusion in Patients Undergoing Major Oncological Surgery

Zhejiang University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Blood Transfusion

Treatments: Procedure: blood volume loss based blood transfusion; Procedure: hemoglobin concentration based blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05607940

2022_XB1028

Details and patient eligibility

About

Investigators aimed to compare the effect on different indications (blood volume loss based VS hemoglobin concentration based ) based blood transfusion practices in patients undergoing major oncological surgery for pelvic or spinal tumor and investigate their postoperative complications.

Full description

260 patients underwent major oncological surgery for open pelvic or spinal tumor resection were included in this study. We looked at white blood cells, hemoglobin, hematocrit, neutrophil ratio, C-reactive protein, erythrocyte sedimentation rate, and IL-6 levels 1 day, 3 days, and 7 days after surgery The main question it sought to answer was whether there was a difference in postoperative complications 30 days after surgery between patients who received blood transfusions based on volume loss and those who received blood transfusions based on hemoglobin concentration during surgery.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 70
• patients with pelvic or spinal tumor
• conduct open resection surgery for tumor removal
• with expected surgery duration greater than 3 hours
• with expected blood loss greater than 400 ml

Exclusion criteria

• age < 18 or >70
• Limb tumor patients or patients with pelvic and spinal tumors undergoing closed internal fixation or vertebroplasty or minimally invasive surgery
• received chemotherapy or immunotherapy before surgery
• with expected surgery length less than 3 hours
• with expected intraoperative blood loss less than 400ml

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

blood volume loss based blood transfusion

Experimental group

Description:

intraoperative blood transfusion begin once blood volume loss over 400ml

Treatment:

Procedure: blood volume loss based blood transfusion

hemoglobin concentration based blood transfusion

Active Comparator group

Description:

intraoperative blood transfusion begin once hemoglobin concentration below 70g/L

Treatment:

Procedure: hemoglobin concentration based blood transfusion