Use of Perftoran Emulsion to Decrease Allogeneic Blood Transfusion in Cardiac Surgery: Clinical Trial

Figures & data

Table 1. Patient demographic characteristics

Patient characteristics	PFC group (n = 15)	Control group (n = 15)
Age (years)	49.9 ± 15.1	52 ± 11.0
Sex (M/F)	7/8	7/8
Weight (Kg)	61.8 ± 7.2	61.7 ± 10.2
BMI	21.1 ± 6.1	22.5 ± 7.5
Valvulopathy (R/D)	8/7	9/6
EBV (L)	4.0 ± 0.5	4.1 ± 0.6

M/F = Male/Female; BMI = Body mass index; R/D = Rheumatic/Degenerative; EBV = Estimated blood volume. Values are mean±SD.

Table 2. Post-acute normovolemic hemodilution characteristics

Clinical parameter	PFC group (n = 15)	Control group(n = 15)
Autologous blood harvested during ANH (mL)	1,189 ± 365	1,280 ± 402
Volume of colloidal solution used for replacement during ANH (mL)	1,232 ± 501	1,430 ± 416
Volume of crystalloid solution used for replacement during ANH (mL)	1,371 ± 319	1,178 ± 417
Systolic Pressure (mm Hg)	103 ± 16	94 ± 15
Diastolic Pressure (mm Hg)	64 ± 14	62 ± 11
MAP (mmHg)	79 ± 15	74 ± 16
CF (beats/min)	68 ± 12	76 ± 16
RF (respirations/min)	19 ± 2	17 ± 2
CVP (mm Hg)	11 ± 2	10 ± 2

ANH = Acute normovolemic hemodilution; MAP = Mean arterial pressure; CF = Cardiac frequency; RF = Respiratory frequency; CVP = Central venous pressure. Values are mean ± SD.

Table 3. Allogeneic blood and blood components transfusion data

	PFC group(n = 15)	Control group(n = 15)	p value
Estimated intraoperative bleeding (mL ± SD)	565 ± 302	440 ± 205	0.18
Patients transfused with pRBC (%)	37.5	60
Mean no. of pRBC units transfused per patient (range)	0.8 (0–4)	1.4 (0–10)	0.16
Patients transfused with CP (%)	6.3	67
Mean no. of CP units transfused per patient (range)	0.4 (0–6)	5.8 (0–10)	<0.001
Patients transfused with Cryo (%)	6.3	47
Mean no. of Cryo units transfused per patient (range)	0.6 (0–10)	3.6 (0–10)	<0.02
Patients transfused with FFP (%)	12.5	87
Mean no. of FFP units transfused per patient (range)	0.3 (0–3)	1.6 (0–5)	<0.002

pRBC = Packed red blood cells (300 mL per unit); CP = Concentrated platelets (70 mL per unit); Cryo = Cryoprecipitate (70 mL per unit); FFP = Fresh frozen plasma (200 mL per unit).

Figure 1 Graph is showing hemoglobin (Hb) concentrations in the group treated with Perftoran (PFC group, n = 15) and in the Control group (n = 15) during the preoperative (t = 0), post-ANH (t = 20), and throughout the intraoperative (t = 20 to t = 200). Significant differences were observed between both groups (*p < 0.05). Each point represents mean ± SD.

Figure 2 Graph is showing PaO₂ during the intraoperative (t = 20 to t = 200). Patients received a FIO₂ of 1.0. Control group represents patients with standard of care. The PFC group represents patients treated with Perftoran. After each one of the two Perftoran infusions, significant increments in PaO₂ in the PFC group were observed (*p < 0.05). Each point represents mean ± SD.

Figure 3 Graph is showing PaCO₂ in the group treated with Perftoran (PFC group) and in the Control group during the preoperative (t = 0), post-ANH (t = 20), and throughout the intraoperative (t = 20 to t = 200). Significant differences between the groups were observed only at 200 minutes (*p < 0.05). Each point represents mean ± SD.

Figure 4 Graph is showing blood pH during the preoperative (t = 0), post-ANH (t = 20) and throughout the intraoperative (t = 20 to t = 200). Control group (n = 15) represents patients with standard of care. PFC group (n = 15) represents patients treated with Perftoran. Each point represents mean ± SD. *p < 0.05 PFC group vs. Control group.

Figure 5 Time course of lactate blood values during the preoperative (t = 0), post-ANH (t = 20), and throughout the intraoperative (t = 20 to t = 200) in patients treated with Perftoran (PFC group) and in patients with standard of care (Control group). Although lactate values were higher most of the time in the PFC group than the Control group, the differences were not statistically significant. Each point represents mean ± SD.

Figure 6 Time course of bicarbonate (HCO₃) blood levels during the preoperative (t = 0), post-ANH (t = 20), and throughout the intraoperative (t = 20 to t = 200) in patients treated with Perftoran (PFC group) and in patients with standard of care (Control group). Each point represents mean ± SD. *p < 0.05 among groups.

Figure 7 Graph showing base excess in blood in patients treated with Perftoran (PFC group, n = 15) and in patients with standard of care (Control group, n = 15) during the preoperative (t = 0), post-ANH (t = 20) and throughout the intraoperative (t = 20 to t = 200). Although there were differences in the levels of base excess between the groups, these were only statistically significant at 200 min (*p < 0.05). Each point represents mean ± SD.

Table 4. Intraoperative characteristics

Parameter	PFC group (n = 15)	Control group (n = 15)
Anesthesia duration (min)	280 ± 24	246 ± 66
Surgery duration (min)	198 ± 30	180 ± 46
CPB duration (min)	86 ± 23	102 ± 46
ACC duration (min)	60 ± 18	72 ± 30

CPB = Cardiopulmonary bypass; ACC = Aortic cross-clamp. Values are mean ± SD.

Table 5. Hematological parameters in the preoperative and the postoperative

	Preoperative		Postoperative
Parameters	PFC group	Control group	PFC group	Control group
RBC (10^6/µL)	4.8 ± 0.7	4.9 ± 0.6	3.5 ± 0.6**	3.9 ± 0.9
Hemoglobin (g/dL)	14.6 ± 1.5	14.8 ± 2	10.4 ± 1.4**	10.9 ± 1.8**
Hematocrit (%)	44 ± 5	45 ± 6	31 ± 5**	32 ± 7**
WBC (10^3/µL)	6.9 ± 2.3	5.7 ± 1.9	13.5 ± 5.5**	11.8 ± 4.1**
PMN cells (10^3/µL)	4.2 ± 1.9	3.4 ± 1.2	11.8 ± 5.0^†	10.6 ± 3.8^†
Mononuclear cells (10^3/µL)	2.8 ± 0.8	2.3 ± 0.9	1.7 ± 1.0**	1.8 ± 0.8**
Platelets (10^3/µL)	210 ± 47	172 ± 46	129 ± 38**	126 ± 38**

RBC = Red blood cells; WBC = White blood cells; PMN = Polymorphonuclear; Mononuclear cells = Lymphocytes and Monocytes. Values are mean ± SD.

*p < 0.05 PFC group vs. Control group.

**p < 0.05 for comparisons between preoperative vs. postoperative values in the same group.

†p < 0.0001 for comparisons between preoperative vs. postoperative values in the same group.

Table 6. Preoperative and postoperative coagulation parameters

	Preoperative		Postoperative
Parameter	PFC group	Control group	PFC group	Control group
PT (s)	15.0 ± 3.5	16.0 ± 3.4	15.5 ± 1.1	16.3 ± 5.3
APTT (s)	47.2 ± 16.0	44.5 ± 16.0	55.2 ± 26.7	49.1 ± 20.6
Activity (%)	65 ± 21	59.2 ± 21.3	56.1 ± 9.5	57.1 ± 20.0
Fibrinogen (mg/dL)	258 ± 51	212 ± 41	224 ± 71	237 ± 67

PT = Prothrombin time; APTT = Activated partial thromboplastin time. Values are mean ± SD.

Table 7. Preoperative and postoperative blood chemistry parameters

	Preoperative		Postoperative
Parameter	PFC group	Control group	PFC group	Control group
Glucose (mg/dL)	107 ± 25	144 ± 77	146 ± 54**	210 ± 139
Urea nitrogen (mg/dL)	37.5 ± 10.1	37.3 ± 12.4	35.7 ± 15.4	29.3 ± 19
Creatinine (mg/dL)	1.0 ± 0.5	1.0 ± 0.3	1.4 ± 0.9	1.2 ± 0.4
Na^+ (mEq/L)	141.2 ± 4.4	139 ± 4	143 ± 4.8	140 ± 6.1
K^+ (mEq/L)	4.4 ± 0.2	4.1 ± 0.6	4.4 ± 0.6	4.3 ± 0.9
Ca + + (mEq/L)	7.1 ± 1.7	9.0 ± 1.5	6.8 ± 1.3	8.8 ± 1.5
Albumin (g/dL)	4.0 ± 0.6	4.4 ± 0.7	3.3 ± 0.6	3.8 ± 0.8
Globulin (g/dL)	2.8 ± 0.6	2.1 ± 1.0	2.7 ± 0.2	2.2 ± 1.4
Ratio A/G	1.5 ± 0.2	2.2 ± 0.8	1.5 ± 0.4	2.6 ± 1.6
Total proteins (g/dL)	6.8 ± 0.9	6.3 ± 1.6	5.1 ± 0.7	5.5 ± 1.5
AP (IU/L)	81 ± 24	72 ± 30	90 ± 24	78 ± 35
CPK (IU/L)	78 ± 40	93 ± 27	243 ± 166**	196 ± 142**
AST (IU/L)	27 ± 12	34 ± 22	65 ± 48**	52 ± 37
ALT (IU/L)	26 ± 16	49 ± 57	46 ± 23	90 ± 114
T-3 (ng/dL)	1.6 ± 0.4	1.9 ± 0.5	1.5 ± 0.4	1.7 ± 0.5
T-4 (µg/dL)	1.0 ± 0.2	1.3 ± 0.8	1.0 ± 0.2	1.2 ± 0.7
Total cholesterol (mg/dL)	175 ± 39	152 ± 56	123 ± 20**	123 ± 41
Triglycerides (mg/dL)	136 ± 66	137 ± 60	93 ± 42	97 ± 43
LDL (mg/dL)	105 ± 40	121 ± 28	101 ± 32	110 ± 28
HDL (mg/dL)	37 ± 10	30 ± 8	34 ± 10	27 ± 10

AP = Alkaline phosphatase; CPK = Creatin phosphokinase; AST = Aspartate aminotransferase; ALT = Alanine aminotransferase; LDL = Low density lipoproteins; HDL = High density lipoproteins. Values are mean ± SD.

*p < 0.05 PFC group vs. Control group.

**p < 0.05 for comparisons between preoperative vs. postoperative values in the same group.