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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Transfusion
• Intervention / Treatment: Procedure: blood volume loss based blood transfusion; Procedure: hemoglobin concentration based blood transfusion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Xiaobo Yan, MD; Phone Number: 13588153306; Email: yanxiaobo82@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blood volume loss based blood transfusion; intraoperative blood transfusion begin once blood volume loss over 400ml	Procedure: blood 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.
Active Comparator: hemoglobin concentration based blood transfusion; intraoperative blood transfusion begin once hemoglobin concentration below 70g/L	Procedure: hemoglobin 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Xiaobo Yan, MD, 2nd Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: blood loss，transfusion，oncological surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 2022_XB1028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No