Whole Blood Transfusion Protocol at the HVCM
Five units of type O+ WB were made available daily and released to patients presenting in hemorrhagic shock, as determined by the attending surgeon taking care of the patient. There is often a delay of only a few minutes in starting a WB transfusion once it is ordered by a physician as five units are always set aside for patients presenting in shock. After the type O+ whole blood is dispensed, the blood bank then proceeds to type and cross the patient using Bio-Rad Saxo ID-Reader. Initial resuscitation was begun in the emergency department and extended into the operating room in most cases, or is begun in the operating room. Given the resource limitations, a warming device was not routinely available. The patient is transfused with WB until vital signs stabilized per the clinical judgment of the attending surgeon, or until the blood bank is depleted of WB, after which type-specific RBCs and FFP are dispensed according to their availability in the blood bank. The decision to transition from WB to component therapy is not based on laboratory parameters at our institution as point-of-care laboratory tests are not available at our institution to allow for rapid decision making. The resuscitation strategy at the HVCM is largely based on clinical exam, as tools such as thrombo-elastography (TEG) used at some institutions to guide blood-based resuscitation are not available.
Blood donation and collection: Whole blood is obtained through voluntary unpaid donation or replacement donation. The blood must be collected in no more than 12 minutes with constant manual or mechanical activation so as to prevent the activation of the clotting cascade. The use of aseptic technique is paramount for quality control and prevention of bacterial contamination. The sterile material utilized in this process is disposable. The extraction bags are quadruple bags including CPD+SAG-Mannitol BUFFY-COAT. The filtration system is used only when the blood is fractionated into components.
WB processing, storage and administration: After a unit of blood is donated, it is quarantined for 8 hours during which time the ABO type and Rh (D) type are determined. The WB is screened for the following serologic markers according to World Health Organization (WHO) standards 14: Syphilis, Hepatitis C, Hepatitis B, and HIV. Plasma antibody titers are not measured prior to the transfusion of WB. If the blood tests negative for infectious diseases, it is stored at 4-6°C and available for 48 hours. As such, the product dispensed at the HVCM is considered cold, fresh whole blood.
Leukoreduction is not routinely performed on the units of WB due to the inability to preserve platelets. After 48 hours, if the blood is not utilized, it is fractionated into components. The red blood cells and frozen plasma are then made available for up 35-42 days and one year respectively. Platelets are not available to patients at the HVCM after fractionation. Given the relative scarcity of blood products in the region, the platelets obtained through fractionation are primarily sent to the local cancer hospital. The blood bank stock is then replaced by the aforementioned methods.
Outcomes of Patients Managed with WB:
Variable
|
Trauma and Acute Care Surgery, n (%)
|
Obstetrics and Gynecology, n (%)
|
Age (years)
|
≤18
|
5 (8.8)
|
2 (4.5)
|
19-39
|
32 (56.1)
|
39 (88.6)
|
40-64
|
15 (26.3)
|
3 (6.8)
|
≥65
|
5 (8.8)
|
0 (0.0)
|
Gender
|
Male
|
45 (78.9)
|
0 (0.0)
|
Female
|
12 (21.1)
|
44 (100.0)
|
Number of WB units transfused in the first 24 hours
|
1
|
26 (45.6)
|
22 (50.0)
|
2
|
23 (40.4)
|
20 (45.5)
|
3
|
6 (10.5)
|
2 (4.5)
|
4
|
1 (1.8)
|
0 (0)
|
5
|
0 (0)
|
0 (0)
|
6
|
1 (1.8)
|
0 (0)
|
Blood Type
|
A+
|
0 (0)
|
2 (4.5)
|
AB+
|
1 (1.8)
|
0 (0)
|
O+
|
56 (98.2)
|
42 (95.5)
|
Table 1. Demographics of patients receiving whole blood transfusion (n=101)
One-hundred-and-one TACS or obstetrics and gynecology patients were identified as receiving resuscitation with WB. Fifty-seven patients presented to the TACS service, and 44 patients presented to the obstetrics and gynecology service with an average shock index of 1.16 (±0.55) (Table 1). Admission vital signs and laboratory values can be found in Table 2.
|
Trauma and Acute Care Surgery (SD)
|
Obstetrics and Gynecology (SD)
|
Systolic blood pressure (mmHg)
|
96.00 (±30.62)
|
99.59 (±23.68)
|
Mean arterial pressure (mmHg)
|
69.11 (±22.98)
|
71.44 (±17.63)
|
Heart rate (beats per minute)
|
100.82 (±26.23)
|
102.50 (±23.91)
|
Respiratory rate (breaths per minute)
|
21.79 (±6.47)
|
20.84 (±3.62)
|
Temperature (Celsius)
|
35.88 (±1.72)
|
35.90 (±1.89)
|
Glasgow Coma Score (GCS)
|
11.32 (±4.85)
|
14.45 (±1.98)
|
Shock Index
|
1.16 (±0.53)
|
1.14 (±0.58)
|
Hemoglobin (g/dL)
|
10.19 (±3.13)
|
8.85 (±2.43)
|
Crystalloid administered in the operating room (mL)
|
2203.13 (±1667.03)
|
1497.94 (±778.78)
|
Colloid administered in the operating room (mL)
|
483.28 (±426.88)
|
400.06 (±438.62)
|
Estimated blood loss (mL)
|
1856.40 (±1577.35)
|
1569.49 (±1115.63)
|
Table 2. Admission vital signs and laboratory values of patients resuscitated with WB
On average, TACS patients received 1.75 (SD ±0.93) units of WB, and obstetrics and gynecology patients received 1.55 (SD ±0.59) units of WB. An average of 1.91 (SD ± 2.68) and 1.74 (SD ± 1.91) units of pRBCs were administered to TACS and obstetrics and gynecology patients respectively after WB. An average of 1.30 (SD ±2.59) and 0.84 (SD ±1.86) units of FFP were administered to TACS and obstetrics and gynecology patients respectively after WB. Platelets, as previously mentioned, are rarely available at our institution.
TACS Patients
Of the 57 patients on the TACS service, 47 were trauma patients and 10 were emergency general surgery patients. Average RTS in the trauma population was 6.06 (±1.89) and average shock index was 1.18 (±51). Anatomic injury data was not available in order to calculate an injury severity score. Of the 47 trauma patients, 24 suffered penetrating trauma and 23 suffered blunt trauma. Hemorrhage was localized in the abdomen in twelve (25.53%) patients, thorax in eleven (23.40%) patients, extremities in ten (21.27%) patients, thorax and abdomen in six (12.76%) patients, face in two (4.26%) patients, pelvis in two (4.26%) patients, spine in one (2.13%) patient, and neck in one (2.13%) patient. In the case of two patients (4.26%), the cause of hemorrhage was unknown as these patients expired prior to complete assessment.
The remaining 10 patients were emergency general surgery patients. Whole blood transfusion was utilized for intraoperative bleeding in a patient undergoing a repair of a ruptured abdominal aortic aneurysm (n=3, 30.00%), an open necrosectomy for infected pancreatic necrosis (n=1, 10.00%), a bowel resection for ischemic gut (n=1, 10.00%), a repair of an iliac artery aneurysm (n=1, 10.00%), repair of the superficial femoral artery following the excision of a left groin mass (n=1, 10.00%), control of gallbladder fossa hemorrhage following a laparoscopic cholecystectomy (n=1, 10.00%), control of splenic hemorrhage following a splenic biopsy (n=1, 10.00%), and control of hypogastric artery bleeding following a spinal surgery (n=1, 10.00%).
Obstetrics and Gynecology Patients
Forty-four patients presented to the obstetrics and gynecology service, with an average shock index of 1.15 (±0.58). Thirty-six patients (81.81%) suffered post-partum hemorrhage either after cesarean section or vaginal delivery. Post-partum hemorrhage was found to be due to uterine atony in eighteen (50.00%) patients, placenta accreta spectrum or placenta previa in eight (22.22%) patients, a tear in the vaginal mucosa in four (11.11%) patients, retained products in three (8.33%) patients, and uterine rupture in two (5.56%) patients. One (2.78%) patient had bleeding from an extrauterine vessel following a cesarean section. The remaining eight patients suffered hemorrhage due to a non-pregnancy-related gynecologic emergency (18.18%) including incomplete abortion in three (37.50%) patients, ruptured ectopic pregnancy in two (25.0%) patients, fibroids in one (12.50%) patient, post-operative bleeding after a hysterectomy in one (12.50%) patient, and a hemorrhagic ovarian cyst in one (12.50%) patient. The only mortality in this cohort expired due to complications related to hemorrhage from HELLP syndrome.
Length-of-stay in the intensive care unit was 4.79 (SD±5.85) days in TACS patients, and 1.84 (SD±2.77) days in obstetrics and gynecology patients. Length of stay was 13.07 (SD±15.33) days in TACS patients, and 5.86 (SD±4.56) days in obstetrics and gynecology patients (Figure 1).
Adverse Outcomes
Importantly, none of the patients in our series developed symptomatology consistent with acute transfusion reaction. This includes anaphylaxis, urticaria, rash, jaundice, and hemoglobinuria per the records from both the nurse and the primary surgical team. No patients were diagnosed with TRALI or TACO in the medical record. However, many of these patients were critically ill, and therefore intubated in the perioperative period making the diagnosis challenging. The cause of death in one trauma patient who suffered massive hemorrhagic shock from a penetrating brachial artery injury was noted to be massive pulmonary edema in the setting of multisystem organ failure. This could be consistent with a diagnosis of TRALI.
Overall mortality was 13.86% in the first 24 hours and 5.94% after 24 hours. The shock index of patients who expired in the first 24 hours and after 24 hours was 1.42 (SD±0.64) and 1.29 (SD±0.48), respectively. By comparison, patients who survived had an average shock index of 1.09 (SD±00.53). Of those patients that expired in the first 24 hours after transfusion, the cause of death was attributed to hemorrhage in eleven patients, three of whom arrested prior to any operative intervention, six of whom arrested in the operating room, and three of whom arrested shortly after surgery. The two remaining patients expired due to a subarachnoid hemorrhage and irreversible shock postoperatively. One death in the maternal population occurred due to hemorrhage in a patient presenting with HELLP syndrome, severe preeclampsia and intrauterine fetal demise. The patient was found to have evidence of severe coagulopathy and a hepatic hematoma after undergoing a cesarean-section; this patient unfortunately died before to operative intervention could be undertaken.
Of the six patients that expired after 24 hours, three suffered sepsis leading to multisystem organ failure. Two patients were declared brain dead and one patient suffered irreversible shock after blunt force trauma to the chest not responsive to treatment.