Does maximum clot elasticity provide real time insights in management of bleeding in pediatric cyanotic congenital heart disease requiring veno-arterial ECMO ? A randomised control trial

Does Maximum clot elasticity provide real time insights in management of bleeding in pediatric cyanotic congenital heart disease requiring Veno-arterial ECMO ? - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111222

Enrollment

Registered

2026-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: Q259- Congenital malformation of great arteries, unspecified

Interventions

Intervention1: In group P, where monitoring and transfusion guided by point of care coagulation test ( ROTEM & Platelet function assay ): ROTEM-based maximum clot elasticity (MCE) measurements and pla

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients with congenital cyanotic heart disease undergoing VA ECMO for cardiac or cardiorespiratory support Informed consent from parent/guardian

Exclusion criteria

Exclusion criteria: Pre-existing severe bleeding diatheseis or thrombophilia not related to CHD/ECMO Patients on preoperative anticoagulation Patients with malignancy, infectious diseases Lack of consent

Design outcomes

Primary

Measure	Time frame
To determine whether maximum clot elasticity(MCE) measured by ROTEM(by EXTEM and FIBTEM assays) predicts major bleeding complications in children with cyanotic congenital heart disease supported on Veno-arterial ECMO.Timepoint: Baseline sample (before ECMO initiation) 24 hours of ECMO 72 hours of ECMO	—

Secondary

Measure	Time frame
1)To compare the prognostic value of MCE & platelet function assays to conventional measures (platelet count, PT/INR, aPTT, ACT) for clot strength & bleeding outcomes. 2)To assess the temporal changes in MCE,MCF & platelet/fibrinogen contributions during the ECMO course & correlate these with outcomes & transfusion requirements.Timepoint: Baseline sample before ECMO initiation 24 hours of ECMO 72 hours of ECMO	—

Measure

Time frame

1)To compare the prognostic value of MCE & platelet function assays to conventional measures (platelet count, PT/INR, aPTT, ACT) for clot strength & bleeding outcomes. 2)To assess the temporal changes in MCE,MCF & platelet/fibrinogen contributions during the ECMO course & correlate these with outcomes & transfusion requirements.Timepoint: Baseline sample before ECMO initiation 24 hours of ECMO 72 hours of ECMO

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Countries

India

Contacts

Public ContactDr Poonam Malhotra Kapoor

All India institute of medical science, new delhi

drpoonamaiims@gmail.com9971000741

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026