NCT06601582

Brief Summary

Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

April 28, 2023

Last Update Submit

September 15, 2024

Conditions

Cardiovascular SurgeryBlood Loss, Surgical

Keywords

Cardiovascular SurgeryOperative Blood Salvage

Outcome Measures

Primary Outcomes (1)

  • Blood transfusion rate

    Reduction in the volume of packed red blood cells administered intrao peratively

    2 days

Secondary Outcomes (6)

  • Hospital mortality

    30 days

  • Hospital Stay

    30 days

  • ICU stay

    30 days

  • Mechanical ventilation

    30 days

  • Re-operation for bleeding

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Device: Use of a operative blood salvage system The surgical team will use a operative blood salvage system

Device: Use of a operative blood salvage system

No intervention

NO INTERVENTION

Interventions

Use of a operative blood salvage systemDEVICE

The surgical team will use a operative blood salvage system

Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details18 years old and older
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients undergoing CABG or Valve surgery singly.

You may not qualify if:

  • Emergency cardiac surgery;
  • Previous heart surgery;
  • End-stage chronic kidney disease;
  • Inability to receive a blood transfusion (refusal);
  • Anemia (hemoglobin less than 10g/dl);
  • Thrombocytopenia (platelet count less than 100,000/mm3);
  • Coagulopathy (RNI \> 1.5);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integral Medicine Institute Professor. Fernando Figueira-IMIP

Recife, Pernambuco, 50070550, Brazil

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Education

Study Record Dates

First Submitted

April 28, 2023

First Posted

September 19, 2024

Study Start

April 1, 2022

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)