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

November 2, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of the postoperative complication
Time Frame: patients 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
patients were carefully followed for complication occurrence 1 month after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
transfusion of red packed blood cells
Time Frame: during hospitalization after surgery, an averagy of 1 week
total volume of blood transfusion calculated after surgery
during hospitalization after surgery, an averagy of 1 week
length of hospital stay
Time Frame: during hospitalization after surgery, an averagy of 1 week
Number of days patients stay in hospital after surgery.
during hospitalization after surgery, an averagy of 1 week
White blood cell count
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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
Time Frame: 1 day，3 days，7 days，and 30 days after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaobo Yan, MD, 2nd Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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