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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Blood Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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blood volume loss based blood transfusion

intraoperative blood transfusion begin once blood volume loss over 400ml

Group Type EXPERIMENTAL

blood volume loss based blood transfusion

Intervention Type PROCEDURE

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

intraoperative blood transfusion begin once hemoglobin concentration below 70g/L

Group Type ACTIVE_COMPARATOR

hemoglobin concentration based blood transfusion

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No