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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05607940
Enrollment
260
Registered
2022-11-07
Start date
2023-01-31
Completion date
2025-12-31
Last updated
2022-11-07

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

Conditions

Blood Transfusion

Keywords

blood loss,transfusion,oncological surgery

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.

Interventions

PROCEDUREblood volume loss based blood transfusion

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.

PROCEDUREhemoglobin concentration based blood transfusion

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
length of hospital stayduring hospitalization after surgery, an averagy of 1 weekNumber of days patients stay in hospital after surgery.
White blood cell count1 day,3 days,7 days,and 30 days after surgeryWhite blood cell count 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 surgeryhemoglobin level 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 surgeryhematocrit was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
transfusion of red packed blood cellsduring hospitalization after surgery, an averagy of 1 weektotal volume of blood transfusion calculated after surgery
C-reactive protein1 day,3 days,7 days,and 30 days after surgeryC-reactive protein 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 surgeryerythrocyte 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 surgeryInterleukin-6 level was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.
neutrophil ratio1 day,3 days,7 days,and 30 days after surgerythe neutrophil ratio was measured in patients 1 day, 3 days, and 7 days and 30 days after surgery.

Contacts

Primary ContactXiaobo Yan, MD
yanxiaobo82@zju.edu.cn13588153306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026