NCT03848507: HYPALB

Impact of Hyperoncotic Albumin to Support Blood Loss Replacement

Completed Phase 4 Last updated 20 February 2020

What this trial tests

Phase 4 trial testing albumin 20% in Blood Loss, Surgical in 24 participants. Completed in 18 February 2020.

Timeline

18 March 2019

Primary endpoint
12 February 2020

18 February 2020

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	18 March 2019
Primary completion	12 February 2020
Estimated completion	18 February 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• albumin 20% — full drug profile →

Conditions studied

• Blood Loss, Surgical — all drugs for Blood Loss, Surgical →
• Fluid Retention — all drugs for Fluid Retention →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

18 and older, any sex, with Blood Loss, Surgical or Fluid Retention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Fluid treatment is usually performed with either balanced crystalloid fluids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids (impairment of renal function and coagulation), and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the 20% albumin solution (endogenous fluid recruitment).

The primary objective of this study is to test the effect of 20% albumin on plasma volume expansion and fluid recruitment in the frame of blood loss replacement during cystectomy using established fluid kinetic models.

The investigators expect that fluid replacement with crystalloid will be better sustained intravascularly with the administration of 20% albumin and be able to recruit fluid into the vascular compartment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plasma disappearance rate of albumin when infused as a 20% solution.
   Zdolsek M, Wuethrich PY, Gunnström M, Zdolsek JH, et al · · 2022 · cited 6× · PMID 35410365 · DOI 10.1186/s13054-022-03979-1
2. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin?
   Hahn RG, Wuethrich PY, Zdolsek JH. · · 2021 · cited 1× · PMID 33957864 · DOI 10.1186/s12871-021-01351-4