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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05607940
Collaborator
(none)
260
2
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: blood volume loss based blood transfusion
  • Procedure: hemoglobin concentration based blood transfusion
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. percentage of the postoperative complication [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

Secondary Outcome Measures

  1. transfusion of red packed blood cells [during hospitalization after surgery, an averagy of 1 week]

    total volume of blood transfusion calculated after surgery

  2. length of hospital stay [during hospitalization after surgery, an averagy of 1 week]

    Number of days patients stay in hospital after surgery.

  3. White blood cell count [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.

  4. hemoglobin level [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.

  5. hematocrit [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.

  6. neutrophil ratio [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.

  7. C-reactive protein [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.

  8. erythrocyte sedimentation rate [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.

  9. nterleukin-6 level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Xiaobo Yan, MD, 2nd Affiliated Hospital Of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT05607940
Other Study ID Numbers:
  • 2022_XB1028
First Posted:
Nov 7, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2022