NCT01528943

Brief Summary

The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 surgery

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 5, 2012

Last Update Submit

March 9, 2021

Conditions

Surgery

Keywords

prostacycline, endothel integrity and abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial biomarkers

    Baseline to 6 hours postoperatively

Secondary Outcomes (1)

  • Functional haemostasis evaluated by thrombelastography

    Baseline to 6 hours postoperatively

Study Arms (2)

Prostacyclin

EXPERIMENTAL

Treatment with prostacyclin

Drug: Prostacycline

Isotonic saline

PLACEBO COMPARATOR

Treatment with isotonic saline

Drug: Isotonic saline

Interventions

ProstacyclineDRUG

Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min

Prostacyclin
Isotonic salineDRUG

same volume as the group that are allocated to prostacycline

Isotonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women above 18 years old
  • Undergoing Whipple surgery or liver resection
  • Able and willing to give informed consent

You may not qualify if:

  • Allergy towards the study medication
  • In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
  • Autoimmune disease
  • Intracranial bleeding within the last 6 months
  • Acute coronary syndrome or myocardial infarction within the last 6 months
  • Congestive heart disease
  • Pregnant or breastfeeding
  • Participating in another clinical study within the last 30 days
  • Liver cirrhosis
  • Need for renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Region Sjælland, 2100, Denmark

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Pär Johansson I Johansson, MD DMSc MPA

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

February 5, 2012

First Posted

February 8, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

January 1, 2014

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

DK(1)