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Testing efficacy of the point-of-care guided hemostatic management in cyanotic congenital cardiac surgery patients.

Evaluation of efficacy of the point-of-care guided hemostatic management in cyanotic congenital cardiac surgery patients using AIIMS algorithm: A prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015122
Enrollment
170
Registered
2018-07-30
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: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: Rotational Thromboelastogram (ROTEM), Sonoclot Analyser and Thromboelastography (TEG) guided hemostatic therapy: In INTERVENTIONAL grouop, patients will be administered blood component

Sponsors

Department Of Science and Technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 170 patients of either gender, belonging to ASA grade I â?? III undergoing elective cardiac surgery on CPB 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 other than inherent coagulopathy associated with cyanotic heart disease. 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
Primary objective â?? To evaluate effect of POC guided hemostatic management on blood component requirements (FFP, Platelets, cryoprecipitate, PRBCs)Timepoint: After reversal with Protamine—

Secondary

MeasureTime frame
a) Postoperative chest drain output b) Number of re-explorations c) Duration of mechanical ventilation d) Duration of ICU stay. e) Duration of hospital stay.Timepoint: 12 and 24 hours postoperatively—

Countries

India

Contacts

Public ContactAmeya Karanjkar

All India Institute Of Medical Sciences

drpoonamaiims@gmail.com9818193507

Outcome results

None listed

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