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Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Plain-language guide to NCT03572088: phase 2 randomized trial of Terlipressin, 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03572088
- Phase
- phase 2
- Status
- completed
- Start
- 2016-05
- Completion (planned or actual)
- 2017-07
- Participants
- 40 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Terlipressin; Blood Loss
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Terlipressin.
The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure.
It had two arms (groups): Terlipresssin (active comparator) and Control (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
40 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: All patients older than 18 years of age,. ASA classification class I and II,. Patients assigned for Whipple procedure.
The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: preoperative renal failure,; severe liver dysfunction (child-turcotte-pugh grade c),; severe valvular heart disease,.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Terlipressin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Terlipressin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2016-05 with completion listed for 2017-07.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Intraoperative blood loss (time frame: intaoperative periods).
It also tracked 4 secondary outcomes, for example Patients needing blood transfusion, Red blood cell units transfused, portal pressure changes and ICU stay.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Terlipressin in 40 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Terlipressin compound page, all human trials.
Our Notes on the Compound
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.