Clinical Outcomes Between Pulsatile and Non-Pulsatile Flo... | NCT07009730

Studies
Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass

NCT07009730

Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Status

Completed

Last Update Posted

Jun 8, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Cardiac Surgery
Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

Bypassing Agents

Countries

Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2019Actual

Primary Completion Date

Jul 22, 2020Actual

Completion Date

Jul 23, 2020Actual

First Submitted Date

May 29, 2025

First Submission Date that Met QC Criteria

Jun 6, 2025

First Posted Date

Jun 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2025

Last Update Posted Date

Jun 8, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ishwor Thapaliya, Principal Investigator, Tribhuvan University Teaching Hospital, Institute Of Medicine.Principal Investigator

Lead Sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiopulmonary bypass, pulsatile flow			Procedure: Bypassing Agents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bypassing Agents	Procedure	Cardiopulmonary bypass surgery, pulsatile flow	Cardiopulmonary bypass, pulsatile flow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU Length of Stay	Measured in days from ICU admission to ICU discharge	12 months

Secondary Outcomes

Measure	Description	Time Frame
Duration of Cardiopulmonary Bypass (CPB)	Measured in minutes from initiation to termination of bypass	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing Atrial Septal Defect closure and Mitral Valve replacement

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All Patients undergoing Atrial Septal Defect closure and mitral Valve replacement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tribhuvan University Teaching Hospital, Institute of Medicine (IOM), Kathmandu, Nepal		Kathmandu		44600	Nepal

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided