Journal Reading

Transfusion Requirement in Surgical Oncology PatientsAnesthesiology 2015; 122:29-38

R1林彥助/ VS余黃平副部長

BackgroundBackground

Restrictive or Liberal erythrocyte transfusion

strategy in patients having major cancer surgery ?strategy in patients having major cancer surgery ?

Materials and MethodsMaterials and Methods

Inclusion Criteria

� All adult patients who had a major surgical procedure for

abdominal cancer and required postoperative care in the ICU

and stay more than 24 h.

Enclusion Criteria

� Age <18 yr

� hematological malignancy

� a Karnofsky score less than 50

� anticoagulation therapy

� active or uncontrolled bleeding

� expected death within 24h of

ICU admission� preexisting anemia (Hb<9 g/dl)

� pre- existing thrombocytopenia

(platelet <50,000/mm3)

� preexisting coagulopathy

(PT>14.8 s)

ICU admission

� ESRD

� pregnancy

� DNR

Major Surgical Procedures

� esophagectomy

� gastrectomy

� gastroduodenopancreatectomy (Whipple procedure)

� retroperitoneal tumor resection

� cytoreductive surgery with heated intrapeitonealchemotherapymy (Whipple procedure)

� hepatectomy or bile duct resection

� radical cystectomy

� partial or total colectomy

heated intrapeitonealchemotherapy

� radical hysterectomy

� emergency laparotomy

Randomization and Masking

� Randomization center

Treatment Protocol

� During their ICU stay:

� Measure Hb at least twice a day

� One erythrocyte unit each time Hb < 7 or 9 g/dl

� Measure Hb after each transfused unit� Measure Hb after each transfused unit

� No further units were given if the goal Hb was obtained

� After ICU discharge:

� the decision to transfuse was left to the discretion of the

physician in charge of the patient clinical care.

� During the 30-day follow-up period, if a patient returned to � During the 30-day follow-up period, if a patient returned to

the ICU for any reason, the allocated transfusion strategy was

maintained

� Leukodepleted erythrocytes, from 250 to 350ml, Hct 70%

Data Collection

� During the ICU stay, assessed daily by a team of three

blinded investigators

� Hb, WBC, CRP, platelet, PT/APTT, Cr, Troponin-I, CK-MB,

Bilirubin, arterial lactate, SvO2, EKG.

Primary Outcome Measures

� Death or Severe clinical complications within 30 days after

the randomization.

� Major cardiovascular complications

(AMI, PE, CHF, cardiac arrest, acute mesenteric ischemia, stroke

and acute peripheral vascular ischemia)and acute peripheral vascular ischemia)

� Septic shock

� AKI requiring renal replacement therapy

� ARDS

� Reoperation

Secondary Outcome Measures

� 30-day incidence of infection

� development of AKI

� need and duration of mechanical ventilation

� duration of vasopressor therapy

� ICU readmission rate

� ICU and hospital lengths of stay

� 60-day mortality

� need for erythrocyte transfusion and the number of units transfused

Statistical Analysis

� Predicted a 40% incidence of the primary outcome based on a

previous study showing rates of 40 to 60%

� 80% statistical power to detect a difference of 20% with a two-

sided α = 0.05 => minimum enrollment of 164 patients sided α = 0.05 => minimum enrollment of 164 patients

� Added 20% to the sample size for subject attrition=197 patients

ResultsResults

Primary Outcome

Variable, % (95% CI) Liberal (N = 97) Rstrictive (N =101) P Value

Primary outcome

(Death or severe

complication at 30 d)

19.6 (12.9–28.6) 35.6 (27.0–45.4 ) 0.012

complication at 30 d)

� ARR (absolute risk reduction)=16% (95% CI, 3.8 to 28.2)

� NNT(number needed to treat)=6.2 (95% CI, 3.5 to 26.5)

Secondary Outcomes

Variable, % (95% CI) Liberal (N = 97) Rstrictive (N =101) P Value

30-d mortality from all

causes

8.2 (4.2–15.4) 22.8 (15.7–31.9) 0.005

60-d mortality from all 11.3 (6.5–19.2) 23.8 (16.5–32.9) 0.022 60-d mortality from all

causes

11.3 (6.5–19.2) 23.8 (16.5–32.9) 0.022

major cardiovascular

events*

5.2 (2.2–11.5) 13.9 (8.4–21.9) 0.038

abdominal infection* 5.2 (2.2–11.5) 14.9 (9.2–23.1) 0.024

Hemoglobin Concentrations & Transfusion

DiscussionDiscussion

Previous Study

1. the Transfusion Requirements After Cardiac Surgery study

2. the Transfusion Trigger Trial for Functional Outcomes in

Cardiovascular Patients Undergoing Surgical Hip Fracture

Repair studyRepair study

Differences between these studies

Preivous Study 1 Preivous Study 2 This Study

elective cardiac surgery both elective and

emergency

higher trigger (8.0 g/dl)

to define the restrictive

8.0 g/dl 7.0 g/dl

to define the restrictive

group

only 3% were

transferred to the ICU

100%

x x leukodepleted blood

x x shorter storage time

Conclusion

In this trail of patients admitted to the ICU after major surgery

for abdominal cancer,

A liberal erythrocyte transfusion strategy (9.0g/dl) was superior

to a restrictive strategy (7.0g/dl) to a restrictive strategy (7.0g/dl)

The EndThe EndThanks for your attention!