The Decision Study

Detection of coagulopathy in paediatric heart surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN55439761

Enrollment

200

Registered

2015-04-22

Start date

2013-05-27

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Blood clotting abnormalities in children after cardiac surgery Haematological Disorders

Interventions

Two 5.25 ml blood samples will be taken from existing intravascular lines at two time-points: 1. Following anaesthetic induction 2. After cessation of CPB, heparin reve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Undergoing cardiac surgery requiring CPB 2. Age =16 years old 3. Weight >2.5 Kg

Exclusion criteria

Exclusion criteria: 1. Emergency operation 2. Isolated Ostium secundum ASD (low bleeding risk) 3. Unable to give informed consent (16 year olds only) 4. In foster care and parents/guardians unavailable to consent

Design outcomes

Primary

Measure	Time frame
The primary clinical outcome is clinical concern about bleeding. We will estimate the association between type of blood clotting abnormality (determined from sample 1 and 2 test results) and clinical concern about bleeding (objective 2) during three time intervals: Interval A: The period between sample 1 and sample 2 Interval B: The period between sample 2 and chest drain on suction Interval C: The first 12 hours after chest drain on suction Clinical concern about bleeding is defined as either: 1. High blood loss. Chest drain volume of either >5ml/Kg /hr in any 1 hour interval or >3 ml/kg/hr for 3 consecutive hours (Hazinski guidelines) in interval C. OR 2. Any non-routine pro-haemostatic treatment given in response to excessive bleeding. This is defined as any of: additional protamine after initial heparin reversal, fresh frozen plasma (FFP), cryoprecipitate, platelets, anti-fibrinolytic drug, recombinant factor 7 (rFVIIa) or fibrinogen concentrate that is given because clinicians consider that excessive bleeding has started to occur. The composite endpoint is necessary because of two important constraints: 1. Blood loss is readily quantified after chest drain insertion by measuring drain volume; however, in intervals A and B (before chest drain on suction), measurement of blood loss is not feasible. 2. Non-routine pro-haemostatic therapies are usually given soon after the start of abnormal bleeding and, if effective, prevent further bleeding. Measuring only ‘high blood loss’ would result in the primary endpoint of excessive bleeding not being identified in these instances. Routine vs non-routine pro-haemostatic therapy There are two circumstances in which clinicians administer pro-haemostatic therapies: 1. As part of standard institutional protocols for	—

Measure

Time frame

The primary clinical outcome is clinical concern about bleeding. We will estimate the association between type of blood clotting abnormality (determined from sample 1 and 2 test results) and clinical concern about bleeding (objective 2) during three time intervals: Interval A: The period between sample 1 and sample 2 Interval B: The period between sample 2 and chest drain on suction Interval C: The first 12 hours after chest drain on suction Clinical concern about bleeding is defined as either: 1. High blood loss. Chest drain volume of either >5ml/Kg /hr in any 1 hour interval or >3 ml/kg/hr for 3 consecutive hours (Hazinski guidelines) in interval C. OR 2. Any non-routine pro-haemostatic treatment given in response to excessive bleeding. This is defined as any of: additional protamine after initial heparin reversal, fresh frozen plasma (FFP), cryoprecipitate, platelets, anti-fibrinolytic drug, recombinant factor 7 (rFVIIa) or fibrinogen concentrate that is given because clinicians consider that excessive bleeding has started to occur. The composite endpoint is necessary because of two important constraints: 1. Blood loss is readily quantified after chest drain insertion by measuring drain volume; however, in intervals A and B (before chest drain on suction), measurement of blood loss is not feasible. 2. Non-routine pro-haemostatic therapies are usually given soon after the start of abnormal bleeding and, if effective, prevent further bleeding. Measuring only ‘high blood loss’ would result in the primary endpoint of excessive bleeding not being identified in these instances. Routine vs non-routine pro-haemostatic therapy There are two circumstances in which clinicians administer pro-haemostatic therapies: 1. As part of standard institutional protocols for

—

Secondary

Measure	Time frame
1. Red cell transfusion expressed as any vs. none and total red cell transfusion volume 2. FFP, platelet and cryoprecipitate transfusion expressed as any vs. none and total volume of each blood component 3. Non-blood component pro-haemostatic treatments (extra protamine, rFVIIa, antifibrinolytic drugs or fibrinogen concentrate) expressed as total dose per Kg body weight of each agent 4. Post-operative complications (including death)	—

Measure

Time frame

1. Red cell transfusion expressed as any vs. none and total red cell transfusion volume 2. FFP, platelet and cryoprecipitate transfusion expressed as any vs. none and total volume of each blood component 3. Non-blood component pro-haemostatic treatments (extra protamine, rFVIIa, antifibrinolytic drugs or fibrinogen concentrate) expressed as total dose per Kg body weight of each agent 4. Post-operative complications (including death)

—

Countries

United Kingdom

Contacts

Public ContactChristine Rogers

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026