Clinical role of human albumin in extracorporeal prime

Prospective randomized controlled trial of human albumin in biopassivation of extracorporeal circuits

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80847914

Enrollment

Registered

2012-02-21

Start date

2009-09-17

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Coronary Artery Disease Circulatory System Atherosclerotic heart disease

Interventions

Patients are randomized with a lottery draw into two groups, Control Group and Study Group. Surgical procedure is identical in both groups, except patients in the Study Group are to receive 50 mL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female between 18 and 70 years of age 2. Any patient presenting for first time, uncomplicated coronary artery bypass surgery at the institution where the study is being performed

Exclusion criteria

Exclusion criteria: 1. Age > 70 years 2. Graft number less than two or more than six 3. Coexistent cardiac disease 4. Re-operation 5. Emergent surgery 6. Pre-operative inotropic support 7. Pre-operative intraaortic balloon pump insertion, or 8. Any deviation from the study protocol

Design outcomes

Primary

Measure	Time frame
1. Arterial blood samples are obtained at three intervals. After induction (Prebypass), 30 minutes after bypass initiation (During), and 15 minutes after protamine administration (Postbypass). All samples are assayed within one hour of collection. 2. Total disaggregated platelet counts are measured with an LH750 analyzer (Beckman Coulter, Mississauga, ON) using whole blood collected in 7.2 mg K2 EDTA blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ) 3. Platelet function is measured with a Dade Behring PFA¨C100 analyzer (Newark, DE, USA) using whole blood collected in 0.105 mol/L sodium citrate blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ). Two assays are run for each sample, one using a collagen/epinephrine (Col/EPI) cartridge, and one with a collagen/adenosine (Col/ADP) cartridge. The PFA¨C100 assay requires a reasonable hematocrit to return valid results, therefore patients with hematocrits falling below 25% are excluded from the study 4. A total 24-hour total chest tube drainage value is obtained by measuring the total chest tube drainage 24 hours after entry to the intensive care unit	—

Measure

Time frame

1. Arterial blood samples are obtained at three intervals. After induction (Prebypass), 30 minutes after bypass initiation (During), and 15 minutes after protamine administration (Postbypass). All samples are assayed within one hour of collection. 2. Total disaggregated platelet counts are measured with an LH750 analyzer (Beckman Coulter, Mississauga, ON) using whole blood collected in 7.2 mg K2 EDTA blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ) 3. Platelet function is measured with a Dade Behring PFA¨C100 analyzer (Newark, DE, USA) using whole blood collected in 0.105 mol/L sodium citrate blood collection tubes (Vacutainer, BD, Franklin Lakes, NJ). Two assays are run for each sample, one using a collagen/epinephrine (Col/EPI) cartridge, and one with a collagen/adenosine (Col/ADP) cartridge. The PFA¨C100 assay requires a reasonable hematocrit to return valid results, therefore patients with hematocrits falling below 25% are excluded from the study 4. A total 24-hour total chest tube drainage value is obtained by measuring the total chest tube drainage 24 hours after entry to the intensive care unit

—

Secondary

Measure	Time frame
1. Demographic information including age, sex, weight are collected 2. Extracorporeal support times and cross clamp times, and urine production	—

Countries

Canada

Outcome results

None listed

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