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Table 1 Outcome measures and their evaluation timepoints

From: Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial

Outcome measures

Timepoints of evaluation

Blood loss: Three methods will be used independently. In the operating room, all blood and fluid aspirated from the abdomen will be measured accurately using graduated suction containers. The amount of irrigation fluid will be carefully monitored and recorded. The weight of all surgical sponges will be measured. This information will be used by (1) the surgeon and (2) anesthesiologist to independently visually estimate blood loss, as is commonly done in clinical practice. In parallel, intraoperative blood loss will also be (3) calculated based on the Flordal equation [56], using preoperative and day 2 hemoglobin levels.

Day 0

Day 2

Packed RBC transfusion

Day 7

Day 30

Other blood product transfusion rate (FFP, cryoprecipitate, albumin, others)

Day 7

Day 30

Overall morbidity rate, major morbidity rate (Clavien-Dindo grade 3a or greater [57]), Comprehensive Complication Index [58] and any perioperative adverse events.

Day 7

Day 30

Mortality

Day 30

Surgeon perception scale (Additional file 3)

Day 0

Intraoperative physiologic parameters (CVP, PPV, total peripheral vascular resistance index, MAP, urine output)

Measured at the onset of surgery (after induction of anesthesia) at various time points

  1. CVP Central venous pressure, FFP Fresh frozen plasma, MAP Mean arterial pressure, PPV Pulse pressure variation, RBC Red blood cell