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

Phase 2
Not yet recruiting
Conditions
Blood Transfusion
Interventions
Procedure: blood volume loss based blood transfusion
Procedure: hemoglobin concentration based blood transfusion
Registration Number
NCT05607940
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Brief Summary

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

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
260
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
blood volume loss based blood transfusionblood volume loss based blood transfusionintraoperative blood transfusion begin once blood volume loss over 400ml
hemoglobin concentration based blood transfusionhemoglobin concentration based blood transfusionintraoperative blood transfusion begin once hemoglobin concentration below 70g/L
Primary Outcome Measures
NameTimeMethod
percentage of the postoperative complicationpatients were carefully followed for complication occurrence 1 month after surgery.

Major postoperative complications include but are not limited to surgical site infection, lung infection, deep vein thrombosis, pressure ulcers and so on

Secondary Outcome Measures
NameTimeMethod
transfusion of red packed blood cellsduring hospitalization after surgery, an averagy of 1 week

total volume of blood transfusion calculated after surgery

length of hospital stayduring hospitalization after surgery, an averagy of 1 week

Number of days patients stay in hospital after surgery.

neutrophil ratio1 day,3 days,7 days,and 30 days after surgery

the neutrophil ratio was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

hemoglobin level1 day,3 days,7 days,and 30 days after surgery

hemoglobin level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

C-reactive protein1 day,3 days,7 days,and 30 days after surgery

C-reactive protein was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

White blood cell count1 day,3 days,7 days,and 30 days after surgery

White blood cell count was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

hematocrit1 day,3 days,7 days,and 30 days after surgery

hematocrit was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

erythrocyte sedimentation rate1 day,3 days,7 days,and 30 days after surgery

erythrocyte sedimentation rate was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

nterleukin-6 level1 day,3 days,7 days,and 30 days after surgery

Interleukin-6 level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

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