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

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).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/034500
Enrollment
200
Registered
2021-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I999- Unspecified disorder of circulatory system

Interventions

Control Intervention1: Nil: Nil

Sponsors

Artemis Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
ââ?¬Â¢Evaluate the Hb levels pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge. ââ?¬Â¢Evaluate the Haematocrit (%) levels pre cardiac surgery and nadir levels during surgery. ââ?¬Â¢Evaluate the inflammatory response post CPB. ââ?¬Â¢Evaluate kidney function through Kidney Function Test post CPB. ââ?¬Â¢Evaluate the platelet count pre cardiac surgery, nadir levels during surgery, post cardiac surgery and at time of discharge.Timepoint: Pre, post CPB 2 hours, 24 hours and at the time of hospital discharge.—

Secondary

MeasureTime frame
ââ?¬Â¢Priming volume used in oxygenator for the surgery (ml). ââ?¬Â¢Amount of blood/blood product transfusion required during surgery (ml). ââ?¬Â¢Incidence and Severity of Acute Kidney Injury. ââ?¬Â¢Duration of Cardiopulmonary Bypass during surgery. ââ?¬Â¢Total duration of the surgery. ââ?¬Â¢Length of ICU stay. ââ?¬Â¢Total length of stay in hospital.Timepoint: During surgery and time of hospital stay.—

Countries

India

Contacts

Public ContactDr Aseem R Srivastava

Artemis Hospital

iitoxy.fx2021@gmail.com7597364480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026