Is blood a necessary component of the perfusate during isolated limb perfusion – a randomized controlled trial

Figures & data

Figure 1. Consort diagram.

Table 1. Baseline characteristics in the intervention group and the control group.

	Intervention group (n = 9 )	Control group (n = 9)	p-value
Age (median, range)	68 ± 46	75 ± 34	.41
Male (%)	7 (78%)	4 (44%)	.34
Weight (kg)	80 ± 12	76 ± 13	.52
Height (cm)	174 ± 7	173 ± 11	.90
Body surface area (m^2)	1.93 ± 0.12	1.90 ± 0.22	.64
Diagnosis melanoma (%)	8 (89%)	8 (89%)	1.00
Diagnosis sarcoma (%)	1 (11%)	1 (11%)	1.00
Hemoglobin (g/L)	142 ± 18	145 ± 9	.63
Hematocrit (%)	40 ± 6	42 ± 5	.58
Creatinine (µmmol/L)	87 ± 11	71 ± 10	.005**
Potassium (mmol/L)	4.3 ± 0.4	4.2 ± 0.2	.56
Treated leg, left (%)	6 (67%)	6 (67%)	1.00
Calculated blood volume in treated extremity (ml)	564 ± 88	532 ± 98	.47
Lactate (mmol/L)	1.0 ± 0.3	1.2 ± 0.7	.37
Reg. ScvO2 in femoral vein (%)	79 ± 7	77 ± 13	.67
Oxygen extraction (%)	21 ± 7	24 ± 14	.62
No co-morbidity (%)	5 (56%)	5 (56%)	1.00
Diabetes (%)	1 (11%)	0 (0%)	1.00
Heart failure (%)	2 (22%)	1 (11%)	1.00
Other co-morbidity (%)	1 (11%)	3 (33%)	.58

Other co-morbidity: hypertension, prostate hyperplasia, ulcerative colitis, asthma, Bechterew, psoriasis and Crohn’s disease.

Mean and SD, median and range, or number and percentage (%). Student’s t-tests for continuous variables and Fisher’s exact test for dichotomous variables were used to compare groups.

**p < .01.

Table 2. Follow-up characteristics.

	Intervention group (n = 9)	Control group (n = 9)	p-value
Wieberdink toxicity (grade I–II) (%)	6 (67%)	5 (56%)	.63
Wieberdink toxicity (grade III) (%)	3 (33%)	3 (33%)	1.0
Wieberdink toxicity (grade IV) (%)	0 (0%)	1 (11%)	.30
Complications, 3 months (%)	1 (11%)	2 (22%)	.52
1-year survival (%)	7 (78%)	6 (67%)	.60
Overall response rate (%)	9 (100%)	7 (78%)	.13
Complete response (%)	5 (56%)	4 (44%)	.64
Partial response (%)	4 (44%)	3 (33%)	.63
Stable disease (%)	0 (0%)	0 (0%)	–
Progressive disease (%)	0 (0%)	2 (22%)	.13

Complications included erysipelas, leg ulcers, advanced leg edema.

Data is reported as mean and SD, median and range, or number and percentage (%). Student’s t-tests for continuous variables and Fisher’s exact test for dichotomous variables were used to compare groups.

Table 3. Treatment characteristics during the perfusion.

	Intervention group (n = 9)	Control group (n = 9)	p-value
ECC time (minutes)	92 ± 12	102 ± 15	.13
Artery closed (minutes)	119 ± 15	139 ± 21	.04*
Beromun (%)	1 (11%)	4 (44%)	.92
Melphalan (mg)	88 ± 8	85 ± 10	.53
Blood waste (ml)	339 ± 365	261 ± 404	.67
Total heparinization (E)	10 511 ± 1 148	10 222 ± 1 369	.63
Venous cannula size (Fr)	17 ± 1	17 ± 2	1.00
Arterial cannula size (Fr)	13 ± 1	12 ± 2	.17
Lactate prime solution (mmol/L)	0.01 ± 0.0	8.1 ± 1.8	.001***
Pumpflow ECC (L/min)	0.74 ± 0.27	0.77 ± 0.18	.82
Sweep gas flow on ECC (L/min)	0.49 ± 0.1	0.49 ± 0.0	.91
FiO2 on ECC (%)	0.45 ± 0.04	0.48 ± 0.02	.05*
CO2 on ECC (L/min)	0.03 ± 0.008	0.03 ± 0.005	.74
Hemoglobin on ECC (g/L)	79 ± 15	98 ± 15	.02*
Hematocrit on ECC (%)	24 ± 6	30 ± 5	.58
Lactate on ECC (mmol/L)	1.6 ± 0.4	3.6 ± 0.7	.001***
SaO2 on ECC (%)	99 ± 0.6	100 ± 0.3	.50
Regional ScvO2 on ECC (%)	83 ± 10	91 ± 4	.07
Arterial oxygen content (ml)	11 ± 2	14 ± 2	.027*
Venous oxygen content (ml)	9 ± 3	12 ± 2	.017*
Delivered oxygen on ECC (ml/min)	90 ± 49	108 ± 38	.39
Oxygen consumption on ECC (ml/min)	14 ± 2	14 ± 5	.85
Oxygen extraction (%)	22 ± 11	14 ± 4	.062
INVOS on treated extremity (%)	76 ± 14	81 ± 11	.42
INVOS on not treated extremity (%)	72 ± 10	66 ± 12	.25

ECC: extracorporeal circulation; FiO₂: fraction of inspired oxygen; CO₂: carbon dioxide; SaO₂: arterial oxygen saturation; ScvO₂: central venous oxygen saturation.

Data is reported as mean and SD, median and range, or number and percentage (%). Student’s t-tests for continuous variables and Fisher’s exact test for dichotomous variables were used to compare groups.

*p < .05,

***p < .001.

Figure 2. Lactate level during isolated limb perfusion. Level during perfusion is shown between the dotted lines: (A) Lactate level (mmol/L).

Figure 3. Hemoglobin level during isolated limb perfusion. Level during perfusion is shown between the dotted lines: (B) Hemoglobin level (g/L).

Figure 4. Regional central venous oxygen saturation level during isolated limb perfusion. Level during perfusion is shown between the dotted lines: (C) Regional ScvO₂ (%).

Figure 5. Oxygen extraction level during isolated limb perfusion. Level during perfusion is shown between the dotted lines: (D) Oxygen extraction (%).

Figure 6. Oxygen delivery level during isolated limb perfusion. (E) Oxygen delivery (ml/min) during perfusion.