NCT07009730

Brief Summary

The aim of this prospective, randomized study was to compare clinical outcomes of Pulsatile and non-pulsatile flow during Cardiopulmonary Bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

May 29, 2025

Last Update Submit

June 6, 2025

Conditions

Cardiac SurgeryCardiac Surgery Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • ICU Length of Stay

    Measured in days from ICU admission to ICU discharge

    12 months

Secondary Outcomes (1)

  • Duration of Cardiopulmonary Bypass (CPB)

    12 months

Study Arms (1)

Cardiopulmonary bypass, pulsatile flow

Procedure: Bypassing Agents

Interventions

Bypassing AgentsPROCEDURE

Cardiopulmonary bypass surgery, pulsatile flow

Cardiopulmonary bypass, pulsatile flow

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Patients undergoing Atrial Septal Defect closure and mitral Valve replacement

You may qualify if:

  • patients undergoing Atrial Septal Defect closure and Mitral Valve replacement

You may not qualify if:

  • Moderate and severe LVEF
  • Patient with bleeding dysfunction;AKI ;deranged liver dysfunction\\
  • Patient/Surrogate decision maker not giving written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal

Kathmandu, 44600, Nepal

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 8, 2025

Study Start

July 23, 2019

Primary Completion

July 22, 2020

Study Completion

July 23, 2020

Last Updated

June 8, 2025

Record last verified: 2025-05

Locations

NE(1)