A study to compare two medical devices during bypass in children.

Recruiting

• Conditions: Unspecified disorder of circulatory system,

• Registration Number: CTRI/2021/06/034500
• Lead Sponsor: Artemis Hospital

Brief Summary

| | |

| --- | --- |

|

Study Title

A Real-world, prospective, multicentre, observational, investigator-initiated study to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB)

|

Background

Neonatal and paediatric cardiac surgery have seen significant advancements in perfusion technology including smaller surface area disposables and lower prime, all tailored to small patient sizes. Reducing the surface area of cardiopulmonary bypass (CPB) and subsequent prime volume is especially important in neonatal patients where the volume from the CPB circuit can be the major determinant in the patient’s metabolic response to the cardiac operation.

Attempts by perfusionists to decrease the circuit prime volume by even a few millilitres can result in a reduction of exogenous blood products. Perfusionists have continuously looked at methods to further reduce CPB prime volumes and often find themselves balancing this goal while maintaining safety.

Despite many advances, CPB for infants continues to have the potential to produce significant morbidity and mortality. With its pro-inflammatory effects, CPB adversely affects several organ systems. There continues to be significant gaps in our knowledge of how to decrease these effects. Continual investigation of modifications to the bypass circuit itself has the potential to decrease inflammation, improve organ function, and ultimately improve morbidity in this patient group.

Selection of individual components in particular type of bypass circuit design can dramatically change the clinical outcome of a patient. Considerable improvement in performance can be notice with significant modifications in Oxygenators. The use of one oxygenator versus another oxygenator continues to be debated in many institutions and within the perfusion community.

The purpose of this Real-world, prospective, observational study is to evaluate the patient outcomes with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for Cardiac Surgery involving Cardiopulmonary Bypass (CPB).

|

Study Objective

To evaluate oxygenator usage associated outcomes in neonates undergoing CPB during cardiac surgery with CAPIOX FX05 integrated arterial filter oxygenator as compared to CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter

|

Study Design

Real world, prospective, multicenter, observational, comparative, investigator-initiated study

|

Study Phase

Real-World Observational study

|

Study Sites

1. Artemis Hospital, Gurgaon

2. Fortis Hospital, Shalimar bagh, New Delhi

3. Sir Gangaram Hospital, New Delhi

4. CIMS Hospital, Ahmedabad

|

Sample size

As such this is a real-world observational study the prospective data on as many patients as possible from whom informed consent has been obtained will be included in the study for the CAPIOX FX05 integrated arterial filter oxygenator and CAPIOX RX05 non- integrated arterial filter oxygenator with external arterial filter for a period of 6 months from the date of initiation of study at site.

|

Study Patients

Inclusion Criteria:

Patients meeting with following criteria to be included in the study:

- Neonates of both gender.

- Neonates who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass with CAPIOX FX05 (1CX\*FX05RW) integrated arterial filter oxygenator.

- Neonates who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass with CAPIOX RX05 (CX\*RX05RW) non- integrated arterial filter oxygenator with external arterial filter.

- Legally acceptable representatives of neonates willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

 

Exclusion Criteria:

Patients meeting with following criteria to be excluded from the study:

- Neonates who are diagnosed with Cyanotic Heart Disease

- Neonates who are or will be on cardiopulmonary bypass for ≥ 2 hours.

- Presence of any other clinically significant disease or laboratory findings that in the Investigator’s opinion may affect the study outcomes.

- Participation in another study concurrently or within 4 weeks prior to the Screening Visit.

|

Study Devices

- CAPIOX FX05 (1CX\*FX05RW) integrated arterial filter oxygenator.

- CAPIOX RX05 (CX\*RX05RW) non- integrated arterial filter oxygenator with external arterial filter.

|

Study Follow-up Duration

Once enrolled into the study the patient’s will be followed-up until they are discharged from the Intensive Care Unit (ICU).

|

Study Timelines

Documentation & Submission – Dec 2020 to Jan 2021

Approvals & Setup – Jan 2021 to March 2021

Patient accrual – April 2021 to Sept 2021

Data collection & analysis – Sept 2021 to Oct 2021

Study report – Nov 2021

|

Primary Outcome

- Evaluate the Haemoglobin (gm/dL) levels pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge.

- Evaluate the Haematocrit (%) levels pre cardiac surgery and nadir levels during surgery.

- Evaluate the inflammatory response post CPB.

- Evaluate kidney function through Kidney Function Test post CPB.

- Evaluate the platelet count pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge.

|

Secondary Outcomes

- Priming volume used in oxygenator for the surgery (ml).

- Amount of blood/blood product transfusion required during surgery (ml).

- Incidence and Severity of Acute Kidney Injury.

- Duration of Cardiopulmonary Bypass during surgery.

- Total duration of the surgery.

- Length of ICU stay.

- Total length of stay in hospital.

|

Safety Outcomes

- Adverse events (AE) or serious adverse events (SAE), noticed by the surgeon/perfusionist will be recorded during the study.

- Surgery procedure related complications.

- Mortality rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Last Update Posted: 2022-12-04

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients meeting with following criteria to be included from the study: 1) Neonates of both gender.
• 2. Neonates who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass with CAPIOX FX05 integrated arterial filter oxygenator.
• 3. Legally acceptable representatives of neonates willing to sign an Informed Consent Form indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria

• Patients meeting with following criteria to be excluded from the study: 1) Neonates who are diagnosed with Cyanotic Heart Disease.
• 2. Neonates who are or will be on cardiopulmonary bypass for more then 2 hours.
• 3. Presence of any other clinically significant disease or laboratory findings that in the investigators opinion may affect the study outcomes.
• 4. Participation in another study concurrently or within 4 weeks prior to the Screening visit.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Evaluate the Hb levels pre cardiac surgery, nadir levels	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
during surgery, post cardiac surgery and at time of	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
discharge.	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
•Evaluate the Haematocrit (%) levels pre cardiac surgery	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
and nadir levels during surgery.	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
•Evaluate the inflammatory response post CPB.	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
•Evaluate kidney function through Kidney Function Test post	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
CPB.	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
of discharge.	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
•Evaluate the platelet count pre cardiac surgery, nadir	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.
levels during surgery, post cardiac surgery and at time	Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.

Secondary Outcome Measures

Name	Time	Method
S	afety Outcomes
•Priming volume used in oxygenator for the surgery (ml).	•Amount of blood/blood product transfusion required during surgery (ml).
Study Phase
Study Sites
Sample size
Secondary Outcomes
Background
Study	Follow-up
Study Design
Study Patients
Study Timelines
Primary Outcome

Trial Locations

Locations (4)

Artemis Hospital; 🇮🇳 Gurgaon, HARYANA, India

CIMS (Care Institute of Medical Sciences); 🇮🇳 Ahmadabad, GUJARAT, India

Fortis Hospital; 🇮🇳 Delhi, DELHI, India

Kokilaben dhirubhai ambani hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Artemis Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Aseem R Srivastava

Principal investigator

9873551375

iitoxy.fx2021@gmail.com