FindTrial
Sign In

To compare three point of care coagulation devices in patient under going cyanotic congenital heart disease.

Comparative evaluation of the three point of care testing devices; Thromboelastograpgh (TEG), Rotational-thromboelastometer (ROTEM) and Sonoclot analyzer in cyanotic congenital cardiac surgery: a correlation with routine laboratory tests and postoperative bleeding.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/12/010725
Enrollment
100
Registered
2017-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Cyanotic Congenital Heart Disease

Interventions

Control Intervention1: Thromboelastograph (TEG), Rotational Thromboelastometer (ROTEM), Sonoclot Analyzer: Viscoelastic bedside Point of Care coagulation blood testing devices Control Intervention2: S

Sponsors

DST
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender aged between one to 50 years, undergoing elective cardiac surgery for cyanotic congenital heart disease will be included in this study.

Exclusion criteria

Exclusion criteria: 1. Patients on preoperative anticoagulants 2. Patients with known coagulopathy 3. Patients undergoing redo surgery 4. Patients undergoing cardiac surgery without involving CPB will not be included in the study.

Design outcomes

Primary

MeasureTime frame
Correlation of the three POC devices (TEG, ROTEM, Sonoclot), parameters with Standard lab coagulation tests.Timepoint: T1-After induction of anaesthesia T2-30 minutes after protamine administration—

Secondary

MeasureTime frame
Correlation of the three POC devices parameters with a) Postoperative chest drain output b) Number of blood products transfused in perioperative period c) Duration of mechanical ventilation d) Duration of ICU stay. Timepoint: T3- 24 hour after ICU admission.—

Countries

India

Contacts

Public ContactPoonam Malhotra

AIIMS, New Delhi

drpoonamaiims@gmail.com9818193507

Outcome results

None listed

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