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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery

Conditions
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Blood Transfusion

Intervention / Treatment
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* Procedure: blood volume loss based blood transfusion
* Procedure: hemoglobin concentration based blood transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blood volume loss based blood transfusion<br>intraoperative blood transfusion begin once blood volume loss over 400ml | Procedure: blood volume loss based blood transfusion<br>* Blood transfusion is indicated based on the estimated intraoperative blood loss. When intraoperative blood loss exceeds 400ml, blood transfusion begin. At the end of the operation, we ensure that the volume of blood transfusion is no greater than the anticipated blood loss.<br>|
| Active Comparator: hemoglobin concentration based blood transfusion<br>intraoperative blood transfusion begin once hemoglobin concentration below 70g/L | Procedure: hemoglobin concentration based blood transfusion<br>* Blood transfusion is indicated based on the intraoperative hemoglobin concentration. Intraoperative blood transfusion begins when hemoglobin concentration is blow 70g/L. Intraoperative blood transfusion stops when hemoglobin concentration reaches 80g/L<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of the postoperative complication | Major postoperative complications include but are not limited to surgical site infection, lung infection, deep vein thrombosis, pressure ulcers and so on | patients were carefully followed for complication occurrence 1 month after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion of red packed blood cells | total volume of blood transfusion calculated after surgery | during hospitalization after surgery, an averagy of 1 week | 
| length of hospital stay | Number of days patients stay in hospital after surgery. | during hospitalization after surgery, an averagy of 1 week | 
| White blood cell count | White blood cell count was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| hemoglobin level | hemoglobin level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| hematocrit | hematocrit was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| neutrophil ratio | the neutrophil ratio was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| C-reactive protein | C-reactive protein was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| erythrocyte sedimentation rate | erythrocyte sedimentation rate was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 
| nterleukin-6 level | Interleukin-6 level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery. | 1 day，3 days，7 days，and 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss，transfusion，oncological surgery