Introduction
Methods
Study design
-
ROTEM 1: baseline value obtained at the start of surgery prior to CPB initiation.
-
ROTEM 2: during the rewarming phase of CPB, prior to PLT administration (occurring after the administration of blood products in the priming phase).
-
ROTEM 3: on CPB after PLT administration.
-
ROTEM 4: after CPB termination, and after protamine and HFC administration.
-
ROTEM 5: after the administration of other blood products if bleeding persisted and ROTEM 4 indicated a deficiency.
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Intervention I: when initiating CPB, for patients less than 10 kg, the pump was primed with 1 U PRBC. If the patient was less than 3 kg, 50 mL of PLT were added to the prime. If the patient was antithrombin III deficient or the heparin management system revealed heparin resistance (based on pre-operative values), 60 mL of fresh frozen plasma (FFP) was added to the prime.
-
Intervention II: administration of PLT given during the rewarming phase of CPB with a median dose of 38 mL/kg.
-
Intervention III: administration of Protamine, and HFC (70 mg/kg; RiaSTAP, CSL Behring, Marburg, Germany) after CPB termination.
-
Intervention IV: further component therapy if bleeding persisted after the HFC and ROTEM indicated a deficiency. This could be further HFC, PLT, FFP or cryoprecipitate
Statistical analysis methods
Results
Overall | Age Groups | pb | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
90 days or less | Older than 90 days to 2 years | Older than 2 years | |||||||||||
Na | Median | IQR | N | Median | IQR | N | Median | IQR | N | Median | IQR | ||
Weight (kg) | 161 | 6.4 | 12.0 | 42 | 3.2 | 0.8 | 64 | 6.2 | 2.8 | 55 | 24.0 | 38.0 |
< 0.001
|
Height (cm) | 161 | 65.0 | 47.0 | 42 | 50.3 | 5.0 | 64 | 64.0 | 10.3 | 55 | 127.0 | 57.0 |
< 0.001
|
Age (days) | 161 | 214.0 | 1324.0 | 42 | 9.5 | 38.0 | 64 | 193.5 | 147.5 | 55 | 2649.0 | 3582.0 |
< 0.001
|
Bypass (min) | 161 | 106.0 | 74.0 | 42 | 146.5 | 64.0 | 64 | 87.0 | 46.0 | 55 | 106.0 | 73.0 |
< 0.001
|
Cross clamp time (min) | 140 | 62.0 | 49.5 | 42 | 82.5 | 56.0 | 52 | 55.5 | 38.0 | 46 | 58.5 | 46.0 | 0.053 |
Regional low flow perfusion (min) | 24 | 102.0 | 66.5 | 22 | 114.5 | 57.0 | 2 | 31.5 | 55.0 | 0 | 0.0 | 0.0 | 0.089 |
Deep hypothermic circulatory arrest (min) | 15 | 15.0 | 41.0 | 12 | 9.5 | 38.0 | 3 | 27.0 | 43.0 | 0 | 0.0 | 0.0 | 0.829 |
Low temperature (c) | 159 | 29.1 | 7.2 | 42 | 17.8 | 7.8 | 64 | 29.4 | 3.3 | 53 | 30.1 | 4.6 |
< 0.001
|
Intervention I | |||||||||||||
Packed red blood cells (mL/kg) | 108 | 62.0 | 52.0 | 42 | 96.5 | 77.0 | 62 | 44.5 | 23.0 | 4 | 13.5 | 14.5 |
< 0.001
|
Plateletpheresis (mL/kg) | 13 | 23.0 | 8.0 | 10 | 22.0 | 8.0 | 3 | 26.0 | 12.0 | 0 | 0.0 | 0.0 | 0.934 |
Fresh frozen plasma (mL/kg) | 27 | 24.0 | 9.0 | 21 | 23.0 | 7.0 | 5 | 26.0 | 8.0 | 1 | 6.0 | 0.0 | 0.055 |
Intervention II | |||||||||||||
Plateletpheresis (mL/kg) | 95 | 38.0 | 29.0 | 40 | 56.0 | 17.5 | 54 | 29.5 | 12.0 | 1 | 18.0 | 0.0 |
< 0.001
|
Intervention III | |||||||||||||
HFC (mg/kg) | 129 | 70.0 | 2.0 | 40 | 70.0 | 1.0 | 58 | 70.0 | 2.0 | 31 | 68.0 | 7.0 |
< 0.001
|
Intervention IV | |||||||||||||
HFC (mg/kg) | 45 | 70.0 | 1.0 | 24 | 70.0 | 1.0 | 19 | 70.0 | 1.0 | 2 | 46.5 | 47.0 | 0.229 |
Plateletpheresis (mL/kg) | 81 | 13.0 | 11.0 | 40 | 19.0 | 13.5 | 40 | 9.0 | 3.5 | 1 | 5.0 | 0.0 |
< 0.001
|
Cell saver (mL/kg) | 151 | 17.0 | 19.0 | 36 | 33.0 | 22.0 | 62 | 19.0 | 9.0 | 53 | 5.0 | 4.0 |
< 0.001
|
Fresh frozen plasma (mL/kg) | 22 | 19.5 | 13.0 | 17 | 20.0 | 9.0 | 4 | 15.5 | 51.5 | 1 | 3.0 | 0.0 | 0.226 |
Packed red blood cells (mL/kg) | 18 | 20.5 | 22.0 | 12 | 25.0 | 13.0 | 4 | 6.5 | 10.0 | 2 | 8.0 | 6.0 |
0.008
|
Cryoprecipitate (mL/kg) | 2 | 10.0 | 0.0 | 1 | 10.0 | 0.0 | 1 | 10.0 | 0.0 | 0 | 0.0 | 0.0 | NA |
Phlebotomized blood (mL/kg) | 19 | 10.0 | 4.0 | 0 | 0.0 | 0.0 | 0 | 0.0 | 0.0 | 19 | 10.0 | 4.0 | NA |
Outcome | Intervention | Estimates | pb | |||
---|---|---|---|---|---|---|
Na | Before (95% CI) | After (95% CI) | Change (95% CI) | |||
HEPTEM CT (sec) | Intervention I | 266 | 206.5 (194.2, 218.9) | 278.4 (264.6, 292.2) | 71.9 (59.8, 83.9) |
< 0.001
|
Intervention II | 206 | 276.2 (264.9, 287.4) | 217.0 (199.7, 234.4) | −59.1 (−79.3, −39.0) |
< 0.001
| |
Intervention III | 219 | 223.7 (204.0, 243.4) | 334.4 (301.1, 367.8) | 110.8 (77.7, 143.8) |
< 0.001
| |
Intervention IV | 189 | 335.6 (248.1, 423.1) | 265.1 (182.5, 347.7) | −70.5 (−102.8, −38.2) |
< 0.001
| |
HEPTEM MCF (mm) | Intervention I | 266 | 60.6 (58.5, 62.7) | 37.9 (35.6, 40.2) | −22.7 (−24.2, −21.2) |
< 0.001
|
Intervention II | 205 | 38.6 (37.0, 40.2) | 55.0 (51.2, 58.8) | 16.4 (12.4, 20.4) |
< 0.001
| |
Intervention III | 217 | 54.9 (51.2, 58.5) | 53.7 (50.4, 57.0) | −1.2 (−3.7, 1.4) | 0.380 | |
Intervention IV | 188 | 54.8 (48.1, 61.5) | 58.0 (51.5, 64.5) | 3.3 (1.1, 5.4) |
0.003
| |
FIBTEM MCF (mm) | Intervention I | 255 | 15.0 (13.0, 16.9) | 4.9 (3.1, 6.7) | −10.1 (−11.0, −9.2) |
< 0.001
|
Intervention II | 196 | 5.1 (4.5, 5.6) | 7.9 (6.8, 9.0) | 2.9 (1.8, 4.0) |
< 0.001
| |
Intervention III | 219 | 7.9 (6.7, 9.1) | 10.5 (9.4, 11.7) | 2.7 (2.0, 3.4) |
< 0.001
| |
Intervention IV | 190 | 10.6 (9.1, 12.1) | 11.2 (9.8, 12.7) | 0.6 (−0.3, 1.6) | 0.197 | |
HEPTEM α (°) | Intervention I | 265 | 75.2 (73.1, 77.1) | 49.3 (45.5, 53.1) | −25.9 (−30.8, −21.0) |
< 0.001
|
Intervention II | 204 | 51.2 (48.7, 53.7) | 73.3 (69.6, 76.5) | 22.1 (16.8, 27.4) |
< 0.001
| |
Intervention III | 217 | 71.3 (67.4, 74.7) | 65.7 (63.0, 68.2) | −5.6 (−8.5, −2.7) |
< 0.001
| |
Intervention IV | 188 | 66.1 (59.8, 71.6) | 69.6 (63.8, 74.3) | 3.4 (1.0, 5.9) |
0.005
|
Analysis of ROTEM parameters by age group
Intervention I: CBP priming and initiation
Outcome | Intervention | Na | Age Group | Estimated ROTEM Values | pb,c | ||
---|---|---|---|---|---|---|---|
Before (95% CI) | After (95% CI) | Change (95% CI) | |||||
HEPTEM CT (sec) | Intervention I | 266 | 90 days or less | 223.2 (202.0, 244.5) | 323.1 (295.9, 350.4) | 99.9 (64.0, 135.8) |
< 0.001
|
Intervention II | 206 | 305.9 (282.3, 329.4) | 221.8 (175.3, 268.3) | −84.0 (−161.1, −7.0) |
0.021
| ||
Intervention III | 219 | 231.5 (185.4, 277.5) | 466.3 (382.7, 550.0) | 234.9 (89.9, 379.8) |
< 0.001
| ||
Intervention IV | 189 | 444.2 (345.7, 542.7) | 291.9 (221.9, 361.9) | −152.3 (−265.6, −39.0) |
0.001
| ||
Intervention I | 266 | Older than 90 days to 2 years | 210.2 (187.5, 232.9) | 293.7 (272.1, 315.3) | 83.5 (66.8, 100.3) |
< 0.001
| |
Intervention II | 206 | 280.0 (266.9, 293.2) | 207.3 (194.9, 219.7) | −72.7 (−90.8, −54.6) |
< 0.001
| ||
Intervention III | 219 | 217.1 (199.7, 234.5) | 298.1 (269.2, 327.0) | 81.0 (51.1, 110.9) |
< 0.001
| ||
Intervention IV | 189 | 294.8 (201.3, 388.2) | 279.4 (176.5, 382.2) | −15.4 (−100.6, 69.8) | 1.000 | ||
Intervention I | 266 | Older than 2 years | 186.1 (166.2, 206.1) | 218.3 (191.9, 244.7) | 32.2 (−5.3, 69.6) | 0.175 | |
Intervention II | 206 | 242.7 (219.9, 265.4) | 207.3 (194.9, 219.7) | −20.7 (−66.7, 25.4) | 1.000 | ||
Intervention III | 219 | 222.5 (204.7, 240.4) | 238.9 (217.5, 260.3) | 16.4 (−5.3, 38.1) | 0.401 | ||
Intervention IV | 189 | 267.8 (159.1, 376.4) | 223.9 (122.0, 325.9) | −43.8 (−76.1, −11.5) |
0.001
| ||
HEPTEM MCF (mm) | Intervention I | 266 | 90 days or less | 62.2 (58.6, 65.7) | 30.1 (26.5, 33.7) | −32.1 (−35.3, −28.8) |
< 0.001
|
Intervention II | 205 | 32.8 (30.1, 35.5) | 58.0 (55.3, 60.7) | 25.2 (21.5, 29.0) |
< 0.001
| ||
Intervention III | 217 | 57.0 (53.5, 60.6) | 55.2 (51.0, 59.3) | −1.9 (−6.8, 3.1) | 1.000 | ||
Intervention IV | 188 | 54.7 (47.6, 61.8) | 58.7 (52.0, 65.5) | 4.0 (−1.8, 9.9) | 0.659 | ||
Intervention I | 266 | Older than 90 days to 2 years | 59.9 (56.4, 63.5) | 36.6 (33.1, 40.2) | −23.3 (−25.5, −21.1) |
< 0.001
| |
Intervention II | 205 | 38.7 (36.6, 40.8) | 56.0 (53.7, 58.4) | 17.3 (13.8, 20.9) |
< 0.001
| ||
Intervention III | 217 | 55.0 (51.8, 58.3) | 55.6 (52.2, 59.0) | 0.6 (−2.5, 3.7) | 1.000 | ||
Intervention IV | 188 | 56.4 (49.6, 63.2) | 58.3 (50.9, 65.7) | 1.9 (−3.8, 7.6) | 1.000 | ||
Intervention I | 266 | Older than 2 years | 59.7 (56.3, 63.1) | 47.0 (42.4, 51.6) | −12.7 (−18.3, −7.2) |
< 0.001
| |
Intervention II | 205 | 44.3 (40.6, 48.0) | 51.0 (40.6, 61.4) | 6.7 (−10.4, 23.8) | 1.000 | ||
Intervention III | 217 | 52.6 (45.2, 60.0) | 50.4 (46.6, 54.2) | −2.2 (−12.1, 7.8) | 1.000 | ||
Intervention IV | 188 | 53.2 (45.5, 61.0) | 57.1 (49.3, 64.8) | 3.9 (−0.9, 8.6) | 0.250 | ||
FIBTEM MCF (mm) | Intervention I | 255 | 90 days or less | 17.0 (13.2, 20.8) | 3.7 (0.3, 7.0) | −13.3 (− 15.9, − 10.7) |
< 0.001
|
Intervention II | 196 | 4.3 (3.4, 5.3) | 8.5 (7.2, 9.8) | 4.2 (2.6, 5.7) |
< 0.001
| ||
Intervention III | 219 | 8.2 (6.7, 9.7) | 10.6 (9.1, 12.1) | 2.4 (0.9, 3.9) |
< 0.001
| ||
Intervention IV | 190 | 10.4 (8.8, 12.0) | 12.5 (10.8, 14.2) | 2.1 (−0.7, 4.9) | 0.396 | ||
Intervention I | 255 | Older than 90 days to 2 years | 15.1 (11.0, 19.2) | 4.3 (0.8, 7.7) | −10.9 (−13.1, −8.6) |
< 0.001
| |
Intervention II | 196 | 4.6 (3.8, 5.5) | 8.3 (7.4, 9.1) | 3.6 (2.8, 4.4) |
< 0.001
| ||
Intervention III | 219 | 7.9 (6.8, 9.0) | 10.1 (8.9, 11.3) | 2.2 (1.0, 3.4) |
< 0.001
| ||
Intervention IV | 190 | 10.2 (8.5, 11.9) | 11.7 (9.6, 13.8) | 1.5 (−0.7, 3.7) | 0.736 | ||
Intervention I | 255 | Older than 2 years | 12.8 (9.2, 16.5) | 6.8 (3.8, 9.7) | −6.1 (− 8.5, −3.7) |
< 0.001
| |
Intervention II | 196 | 6.2 (4.8, 7.6) | 7.0 (4.5, 9.5) | 0.8 (− 3.8, 5.4) | 1.000 | ||
Intervention III | 219 | 7.5 (5.8, 9.3) | 10.9 (9.5, 12.3) | 3.4 (0.9, 5.9) |
< 0.001
| ||
Intervention IV | 190 | 11.2 (9.3, 13.1) | 9.6 (7.5, 11.6) | −1.6 (−4.3, 1.0) | 1.000 | ||
HEPTEM α (°)b | Intervention I | 265 | 90 days or less | 77.0 (73.7, 79.7) | 36.6 (31.2, 42.2) | −40.4 (−50.4, −30.5) |
< 0.001
|
Intervention II | 204 | 42.1 (37.8, 46.4) | 74.9 (72.1, 77.4) | 32.9 (23.2, 42.5) |
< 0.001
| ||
Intervention III | 217 | 72.8 (69.8, 75.4) | 63.9 (60.0, 67.4) | −8.9 (−15.0, −2.8) |
< 0.001
| ||
Intervention IV | 188 | 64.4 (57.6, 70.3) | 70.2 (64.0, 75.2) | 5.7 (0.3, 11.2) |
0.038
| ||
Intervention I | 265 | Older than 90 days to 2 years | 75.0 (71.4, 78.0) | 49.5 (43.7, 55.1) | −25.5 (−32.8, −18.3) |
< 0.001
| |
Intervention II | 204 | 54.0 (50.5, 57.3) | 74.9 (72.4, 77.1) | 20.9 (13.9, 28.0) |
< 0.001
| ||
Intervention III | 217 | 72.4 (69.7, 74.8) | 67.9 (64.7, 70.8) | −4.5 (−8.2, −0.8) |
< 0.001
| ||
Intervention IV | 188 | 67.8 (61.1, 73.3) | 68.7 (61.6, 74.5) | 0.9 (−1.2, 3.0) | 1.000 | ||
Intervention I | 265 | Older than 2 years | 73.4 (69.6, 76.7) | 61.3 (55.1, 66.9) | −12.1 (− 19.5, −4.8) |
< 0.001
| |
Intervention II | 204 | 57.4 (51.2, 63.1) | 69.8 (57.0, 78.6) | 12.4 (−3.3, 28.1) | 1.000 | ||
Intervention III | 217 | 68.6 (56.9, 77.1) | 65.3 (61.9, 68.3) | −3.4 (−9.0, 2.3) | 1.000 | ||
Intervention IV | 188 | 66.1 (58.5, 72.4) | 69.8 (62.8, 75.4) | 3.7 (−1.0, 8.4) | 1.000 |