NCT05607940

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2023

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 7, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

October 28, 2022

Last Update Submit

November 2, 2022

Conditions

Blood Transfusion

Keywords

blood loss，transfusion，oncological surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • transfusion of red packed blood cells

    during hospitalization after surgery, an averagy of 1 week

  • length of hospital stay

    during hospitalization after surgery, an averagy of 1 week

  • White blood cell count

    1 day，3 days，7 days，and 30 days after surgery

  • hemoglobin level

    1 day，3 days，7 days，and 30 days after surgery

  • hematocrit

    1 day，3 days，7 days，and 30 days after surgery

  • +4 more secondary outcomes

Study Arms (2)

blood volume loss based blood transfusion

EXPERIMENTAL

intraoperative blood transfusion begin once blood volume loss over 400ml

Procedure: blood volume loss based blood transfusion

hemoglobin concentration based blood transfusion

ACTIVE COMPARATOR

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

Procedure: hemoglobin concentration based blood transfusion

Interventions

blood volume loss based blood transfusionPROCEDURE

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.

blood volume loss based blood transfusion
hemoglobin concentration based blood transfusionPROCEDURE

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

hemoglobin concentration based blood transfusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xiaobo Yan, MD

    2nd Affiliated Hospital Of Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaobo Yan, MD

CONTACT

13588153306yanxiaobo82@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 7, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

November 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share