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Influence of Argipressin on blood loss during liver resection; a double-blinded, randomized, placebo-controlled trial (ARG-01)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514332-25-00
Acronym
ARG-01
Enrollment
248
Registered
2024-11-14
Start date
2022-03-27
Completion date
2025-02-17
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic resection due to primary malignant disease, metastasis or benign tumour

Brief summary

Blood loss (ml) at the end of surgery, measured according to the investigator’s instructions, by visual assessment of suction devices and gauze, and subtraction of ascites and irrigation fluids.

Detailed description

Blood transfusion (ml) at the end of surgery, and at postoperative day 1 and postoperative day 2 or 5, respectively as well as plasma and thrombocytes day 2/5., Levels of WBC, CRP, PLT and Albumin at the end of surgery and postoperative day 1-5., Levels of IL-1b IL-6, IL-8, IL-10, MCP-1, SDF-1a, ICAM, C3a, C5b-9 at the end of surgery and postoperative day 1 and 2., ROTEM, vWF activity, factor VIII at the end of surgery and postoperative day 1., Plasma creatinine will be controlled at postoperative day 1, 2 and 5. Urine [TIMP-2] x [IGFBP-7] will be controlled after surgery., Hs-TNI will be controlled at the end of surgery and at postoperative day 1., Arterial lactate will be controlled at the end of surgery, at three hours after surgery and at postoperative day 1., IFABP will be controlled at three hours after surgery and postoperative day one., Vasopressor use during surgery, achievement of CVP goal, total urine output and use of furosemide at postoperative day 1., Measurements of mean arterial blood pressure (MAP), heart rate, CVP and Cardiac Index (if applicable), as well as assessment of capillary refill time in digits at the end of surgery., Total time of surgical hepatic occlusion and radicality of resection, as well as use of TXA., Length of stay in hospital and postoperative complications documented at postoperative day 30.

Interventions

DRUGlösning
DRUGNatriumklorid Braun 9 mg/ml injektionsvätska

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Blood loss (ml) at the end of surgery, measured according to the investigator’s instructions, by visual assessment of suction devices and gauze, and subtraction of ascites and irrigation fluids.

Secondary

MeasureTime frame
Blood transfusion (ml) at the end of surgery, and at postoperative day 1 and postoperative day 2 or 5, respectively as well as plasma and thrombocytes day 2/5., Levels of WBC, CRP, PLT and Albumin at the end of surgery and postoperative day 1-5., Levels of IL-1b IL-6, IL-8, IL-10, MCP-1, SDF-1a, ICAM, C3a, C5b-9 at the end of surgery and postoperative day 1 and 2., ROTEM, vWF activity, factor VIII at the end of surgery and postoperative day 1., Plasma creatinine will be controlled at postoperative day 1, 2 and 5. Urine [TIMP-2] x [IGFBP-7] will be controlled after surgery., Hs-TNI will be controlled at the end of surgery and at postoperative day 1., Arterial lactate will be controlled at the end of surgery, at three hours after surgery and at postoperative day 1., IFABP will be controlled at three hours after surgery and postoperative day one., Vasopressor use during surgery, achievement of CVP goal, total urine output and use of furosemide at postoperative day 1., Measurements of mean

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026