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

Blood Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05607940
• Other study ID #: 2022_XB1028
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaobo Yan, MD
• Phone: 13588153306
• Email: yanxiaobo82[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	transfusion of red packed blood cells	total volume of blood transfusion calculated after surgery	during hospitalization after surgery, an averagy of 1 week
Secondary	length of hospital stay	Number of days patients stay in hospital after surgery.	during hospitalization after surgery, an averagy of 1 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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