Plasma-Free Strategy for Cardiac Surgery with Cardiopulmonary Bypass in Infants < 10 kg: A Retrospective, Propensity-Matched Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patient Population and Propensity Matching
2.2. Anesthesia, CPB, Surgery, and ICU Management
2.3. Interventions
2.4. Data Collection and Measurements
2.5. Bleeding Treatment Protocol
- Correction of residual heparin, if the CT at INTEM exceeded by 20%, the CT at HEPTEM
- Fibrinogen concentrate (Haemocomplettan or Riastap, CSL Behring, Marburg, Germany) 30 mg kg−1 if FIBTEM MCF < 8 mm or Clauss fibrinogen < 150 mg dL−1 in the FFP-free group, and/or FFP in the FFP-based group.
- Platelet concentrates if EXTEM MCF < 35 mm and FIBTEM MCF ≥ 8 mm or platelet count < 100,000 cells/µL. In case of persisting bleeding with an EXTEM MCF < 35 mm, platelet concentrates could be repeated regardless of FIBTEM MCF values.
- 4-factors PCC (Confidex, CSL Behring, Marburg, Germany or Pronativ, Octapharma, Lachen, Switzerland) 20 IU kg−1 if EXTEM CT > 100 (after correction of fibrinogen and platelet values) or prothrombin activity < 50% in the FFP-free group, and/or FFP in the FFP-based group.
- Additional tranexamic acid (30 mg kg−1) in the presence of VET signs of hyperfibrinolysis.
- Surgical re-exploration if bleeding persisted after correction of the above factors.
2.6. Sample Size and Statistics
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variable | FFP-Free (n = 18) | FFP-Based before Matching (n = 53) | ASMD Pre-Match | FFP-Based after Matching (n = 27) | ASMD Post-Match |
---|---|---|---|---|---|
Age (months) | 7.00 (7.0) | 7.02 (7.3) | 0.00 | 6.3 (4.6) | 0.12 |
Weight (kg) | 5.46 (2.01) | 5.62 (2.14) | −0.08 | 5.6 (2.0) | −0.07 |
Preoperative hematocrit (%) | 39.4 (6.3) | 36.6 (7.5) | 0.40 | 38.5 (8.6) | 0.12 |
aPTT (sec) | 33.2 (12.5) | 32.7 (4.9) | 0.05 | 32.4 (4.9) | 0.08 |
PT (%) | 88.3 (20.5) | 90.3 (13.1) | −0.12 | 90.8 (13.7) | −0.14 |
Platelet count (×1000 cells/µL) | 363 (113) | 334 (122) | 0.25 | 357 (136) | 0.05 |
Cardiopulmonary bypass time (min) | 91 (38) | 108 (48) | −0.39 | 96 (45) | −0.12 |
Nadir hematocrit on CPB (%) | 30.2 (3.2) | 30 (2.8) | 0.07 | 30.7 (3.0) | −0.16 |
Nadir temperature on CPB (°C) | 31.1 (3.6) | 30.9 (2.9) | 0.06 | 31.6 (3.1) | −0.15 |
RACHS II | 2.5 (1.5) | 2.1 (0.91) | 0.32 | 2.36 (1.05) | 0.15 |
Redo surgery | 4 (22.2) | 4 (7.5) | 0.42 | 5 (18.5) | 0.09 |
Urgent surgery | 5 (27.8) | 8 (15.1) | 0.31 | 7 (25.9) | 0.04 |
Item | FFP-Free (n = 18) | FFP-Based (n = 27) | Mean Difference (95% CI) | p | |
---|---|---|---|---|---|
aPTT (sec) | |||||
Baseline | 33.2 (12.5) | 32.7 (4.9) | −0.87 (−6.24 to 4.48) | 0.743 | |
Arrival ICU | 39.0 (7.5) | 33.6 (4.1) | −5.5 (−9.0 to −2.2) | 0.003 | |
24 h | 37.8 (8.3) | 36.5 (7.5) | −1.32 (−6.14 to 3.48) | 0.581 | |
48 h | 40.4 (7.5) | 40.7 (11.3) | 0.22 (−6.66 to 7.11) | 0.948 | |
Prothrombin activity (%) | |||||
Baseline | 88.3 (20.5) | 90.3 (13.1) | 2.53 (−9.83 to 14.9) | 0.679 | |
Arrival ICU | 48.8 (11) | 69.1 (10.5) | 20.3 (12.8 to 27.8) | 0.001 | |
24 h | 55.3 (12.6) | 62.3 (8) | 7.54 (0.06 to 15) | 0.048 | |
48 h | 57.8 (9.4) | 65.3 (12.9) | 7.52 (−5.64 to 20.7) | 0.250 | |
Platelet count (×1000 cells/µL) | |||||
Baseline | 363 (113) | 357 (136) | −6.5 (−85 to 72) | 0.868 | |
Arrival ICU | 147 (48) | 146 (74) | −1.7 (−41 to 38) | 0.931 | |
24 h | 153 (51) | 146 (54) | −7.8 (−41 to 25) | 0.635 | |
48 h | 141 (50) | 159 (71) | 18.4 (−20 to 57) | 0.345 | |
Fibrinogen (mg dL−1) | |||||
Arrival ICU | 156 (50) | 202 (45) | 46 (17 to 75) | 0.002 | |
24 h | 214 (71) | 258 (55) | 44 (6 to 82) | 0.023 | |
48 h | 271 (110) | 393 (91) | 123 (50 to 195) | 0.002 | |
EXTEM CT (sec) | |||||
Post-protamine | 108 (27) | 93 (39) | −14.8 (−36.5 to 6.98) | 0.178 | |
24 h | 88 (19) | 78 (16) | −10.2 (−21 to 0.6) | 0.064 | |
48 h | 82 (20) | 87 (22) | 5.1 (−8.8 to 19) | 0.462 | |
HEPTEM CT (sec) | |||||
Post-protamine | 312 (76) | 272 (92) | −40.3 (−101 to 20.5) | 0.186 | |
24 h | 294 (107) | 290 (138) | −4.1 (−91.5 to 83) | 0.924 | |
48 h | 270 (81) | 247 (70) | −23.2 (−86 to 39.6) | 0.454 | |
EXTEM MCF (mm) | |||||
Post-protamine | 44 (8) | 52 (8) | 8.7 (3.6 to 13.8) | 0.001 | |
24 h | 54 (8) | 58 (6) | 4.4 (0.20 to 8.7) | 0.041 | |
48 h | 55 (10) | 60 (6) | 5.5 (0.22 to 10.7) | 0.041 | |
FIBTEM MCF (mm) | |||||
Post-protamine | 4.7 (2.1) | 11 (6.3) | 6.3 (3.2 to 9.4) | 0.001 | |
24 h | 10 (3.8) | 15.7 (6.2) | 5.7 (2.3 to 9) | 0.001 | |
48 h | 12.5 (6.5) | 20.5 (5.9) | 8.0 (3.9 to 12) | 0.001 |
Item | FFP-Free (n = 18) | FFP-Based (n = 27) | Mean Difference (95% CI) | p |
---|---|---|---|---|
Bleeding (cumulative, mL kg−1) | ||||
12 h | 16.7 (12) | 14.5 (9.4) | −2.2 (−8.7 to 4.3) | 0.501 |
24 h | 31.9 (27.1) | 24.2 (16.3) | −7.7 (−20.8 to 5.3) | 0.239 |
48 h | 58.5 (66) | 37 (25.6) | −21.5 (−49.8 to 7.8) | 0.133 |
Packed red cells transfusions (mL kg−1) | ||||
Priming volume | 22.9 (7.2) | 23.1 (8.2) | 2.4 (−4.7 to 4.9) | 0.863 |
After protamine in the OR | 11.5 (7.1) | 11 (8.4) | 2.4 (−5.4 to 4.3) | 0.821 |
Postoperative 24 h | 11.2 (9.3) | 11.6 (9.5) | 2.9 (−5.3 to 6.24) | 0.875 |
Postoperative 48 h | 4.3 (7.3) | 2.3 (6.0) | −2 (−6 to 2) | 0.312 |
Total | 50 (19.2) | 48 (23) | −2 (−15 to 11) | 0.761 |
FFP transfusions (mL kg−1) | ||||
Priming volume | 0 | 29.4 (13.8) | 29.4 (22.8 to 36) | 0.001 |
After protamine in the OR | 0 | 4.4 (5.1) | 4.4 (2 to 6.9) | 0.001 |
Postoperative 24 h | 0 | 1.8 (5.9) | 1.9 (−0.01 to 3.74) | 0.051 |
Postoperative 48 h | 0 | 0 | 0 | N/A |
Total | 0 | 8.1 (18.3) | 33.9 (26.3 to 41.4) | 0.001 |
Platelet transfusions (mL kg−1) | ||||
After protamine in the OR | 1.14 (3.3) | 1.28 (3.5) | 0.15 (−1.95 to 2.24) | 0.890 |
Postoperative 24 h | 0 | 0.18 (1.0) | 0.19 (−0.27 to 0.64) | 0.420 |
Postoperative 48 h | 0 | 0 | 0 | N/A |
Total | 1.13 (3.3) | 1.46 (3.8) | 0.33 (−1.9 to 2.6) | 0.766 |
Fibrinogen concentrate (mg kg−1) | ||||
OR and ICU | 23.4 (20) | 4.3 (10.5) | −19.1 (−28.3 to −9.84) | 0.001 |
PCC (IU kg−1) | ||||
OR and ICU | 5.6 (9.2) | 0.74 (3.8) | −4.8 (−8.8 to −0.81) | 0.020 |
Item | FFP-Free (n = 18) | FFP-Based (n = 27) | p |
---|---|---|---|
Surgical revision due to bleeding | 0 (0) | 0 (0) | N/A |
Inotropic drugs > 48 h | 9 (50) | 13 (52) | 0.897 |
Bloodstream infection | 3 (17) | 1 (4) | 0.190 |
Hospital mortality | 1 (5.6) | 0 (0) | 0.419 |
Peak serum creatinine (mg dL−1) | 0.59 (0.20) | 0.46 (0.16) | 0.020 |
Blood lactates arrival ICU (mmol L−1) | 1.85 (1.30) | 1.74 (0.67) | 0.722 |
Mechanical ventilation (hours) | 77 (84) | 53 (55) | 0.257 |
ICU stay (days) | 4 (2–9) | 4 (2–7) | 0.674 |
Postoperative hospital stay (days) | 15 (12–23) | 14 (8–17) | 0.236 |
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Ranucci, M.; Di Dedda, U.; Isgrò, G.; Giamberti, A.; Cotza, M.; Cornara, N.; Baryshnikova, E. Plasma-Free Strategy for Cardiac Surgery with Cardiopulmonary Bypass in Infants < 10 kg: A Retrospective, Propensity-Matched Study. J. Clin. Med. 2023, 12, 3907. https://doi.org/10.3390/jcm12123907
Ranucci M, Di Dedda U, Isgrò G, Giamberti A, Cotza M, Cornara N, Baryshnikova E. Plasma-Free Strategy for Cardiac Surgery with Cardiopulmonary Bypass in Infants < 10 kg: A Retrospective, Propensity-Matched Study. Journal of Clinical Medicine. 2023; 12(12):3907. https://doi.org/10.3390/jcm12123907
Chicago/Turabian StyleRanucci, Marco, Umberto Di Dedda, Giuseppe Isgrò, Alessandro Giamberti, Mauro Cotza, Noemi Cornara, and Ekaterina Baryshnikova. 2023. "Plasma-Free Strategy for Cardiac Surgery with Cardiopulmonary Bypass in Infants < 10 kg: A Retrospective, Propensity-Matched Study" Journal of Clinical Medicine 12, no. 12: 3907. https://doi.org/10.3390/jcm12123907