Clinical trial NCT05607940: Effect of Indication Based Blood Product Transfusion in Patients Undergoing Major Oncological Surgery
Official title: A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Blood Transfusion
Keywords: blood loss，transfusion，oncological surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of the postoperative complication
timeFrame: patients were carefully followed for complication occurrence 1 month after surgery.
Secondary outcomes:
measure: transfusion of red packed blood cells
timeFrame: during hospitalization after surgery, an averagy of 1 week
measure: length of hospital stay
timeFrame: during hospitalization after surgery, an averagy of 1 week
measure: White blood cell count
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: hemoglobin level
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: hematocrit
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: neutrophil ratio
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: C-reactive protein
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: erythrocyte sedimentation rate
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
measure: nterleukin-6 level
timeFrame: 1 day，3 days，7 days，and 30 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: 2nd Affiliated Hospital Of Zhejiang University
name: Xiaobo Yan, MD
role: PRINCIPAL_INVESTIGATOR
References: