Table 1.
Characteristics of patients enrolled in the study but not randomly allocated or who were enrolled in the study and randomly allocated. Values are median (IQR [range]), number (proportion) or mean (SD).
|
Enrolled but not randomly allocated n = 84 |
Enrolled and randomly allocated n = 50 |
||
|---|---|---|---|
|
PCC n = 25 |
FFP n = 25 |
||
| Age; years | 68 (57–76 [25–85]) | 69 (63–73 [28–85]) | 66 (57–74 [ 41–88]) |
| Sex; male | 53 (63.1%) | 16 (64.0%) | 16 (64.0%) |
| Ethnicity | |||
| White | 66 (85.7%) | 21 (95.5%) | 20 (90.9%) |
| Asian | 6 (7.8%) | 1 (4.6%) | 1 (4.6%) |
| African | 4 (5.2%) | 0 (0%) | 1 (4.6%) |
| Mixed | 1 (1.3%) | 0 (0%) | 0 (0%) |
| Weight; kg | 78.0 (17.3) | 76.1 (19.7) | 80.5 (16.2) |
| Height; cm | 170 (10) | 167 (10) | 168 (11) |
| BMI; kg.m−2 | 27 (6) | 27 (6) | 29 (5) |
| EuroSCORE; % | 2 (1–4 [1–18]) | 4 (2–6 [1–15]) | 3 (2–5 [1–46]) |
| Medical history | |||
| Diabetes mellitus | 13 (16.5%) | 6 (24.0%) | 6 (24.0%) |
| Hypertension | 50 (63.3%) | 19 (76.0%) | 13 (52.0%) |
| Angina | 12 (15.2%) | 6 (24.0%) | 6 (24.0%) |
| Previous PCI | 2 (2.5%) | 3 (12.0%) | 2 (8.0%) |
| Previous cardiac surgery | 4 (5.1%) | 2 (8.0%) | 1 (4%) |
| Elective surgery | 71 (89.9%) | 19 (76.0%) | 20 (80.0%) |
| Procedure | |||
| Valve only | 34 (40.5%) | 5 (20.0%) | 7 (28.0%) |
| Major aortic valve only | 3 (3.6%) | 2 (8.0%) | 0 (0.0%) |
| CABG + valve | 17 (20.2%) | 6 (24.0%) | 5 (20.0%) |
| Complex/combined procedure | 30 (35.7%) | 12 (48.0%) | 13 (52.0%) |
| Medication | |||
| Antiplatelet | 1 (1.2%) | 7 (28.0%)* | 7 (28.0%) † |
| Anticoagulant | 7 (8.3%) | 9 (36.0%) | 7 (28.0%) |
| EQ5D index score | 0.9 (0.7–0.9 [0.0–1.0]) | 0.9 (0.8–1.0 [0.3–1.0]) | 0.9 (0.7–1.0 [0.4–1.0]) |
| Laboratory tests at screening (pre‐surgery) | |||
| Haemoglobin; g.l−1 | 133 (124–143 [104–167]) | 130 (124–141 [109–152]) | 135 (121–145 [95–166]) |
| Platelets; ×109.l−1 | 227 (184–271 [107–423]) | 239 (194–259 [139–314]) | 233 (176–296 [123–366]) |
| PT; s | 11 (11–12 [10–18]) | 11 (11–12 [10–17]) | 11 (11–12 [10–13]) |
| APTT; s | 26 (24–28 [21–36]) | 27 (25–29 [21–35]) | 25 (23–27 [21–67]) |
PCC, prothrombin complex concentrate; FFP, fresh frozen plasma; PCI, percutaneous coronary interventions; EQ5D, health questionnaire; CABG, coronary artery bypass grafts; PT, prothrombin time; APTT, activated partial thromboplastin time.
*
7 PCC patients were taking antiplatelet medication (4 aspirin, 3 clopidogrel).
†
7 FFP patients were taking aspirin and of these one was on both aspirin and clopidogrel.