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Table 5 Flow chart of the IVC CLAMP-Trial.

From: IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisciplinary setting

 

Screening

Intervention

Follow up

  
 

Visit 1

(up to 30 days before surgery)

Visit 2

(day of surgery)

Visit 3

(POD 1)

Visit 4

(POD 3)

Visit 5

(POD 7 or day of discharge)

Selection criteria

Informed consent

X

    

Medical history

Demographics

X

    

Physical examination

X

    

Laboratory tests1

X

 

X

X

X

Intraoperative outcomes

 

X

   

Postoperative outcomes

    

X

  1. 1For detailed description of laboratory test done see table 6. POD, Postoperative day
  2. Past/current medical history: past/current medical/surgical history i.e. concomitant/underlying illness (indication for surgery)
  3. Demographics: age [years], sex, ASA-class [26], NYHA-class [16]
  4. Physical examination: height [m], body weight [kg], smoking habits [packs/day, pack years]
  5. Intraoperative outcome measures: intraoperative blood loss, intraoperative PRBC transfusion, haemodynamics/haemodynamic instability, operation time, transection time, transection area, use of portal triad clamping, performed resection type/extent, transection technique, and mortality
  6. Postoperative outcome measures: postoperative RPBC transfusion (until 48 h), postoperative complications/morbidity, duration of hospital stay, duration of ICU stay, mortality