Effect of Prostacyclin on Haemostasis in Abdominal Surgery

NCT ID: NCT01528943

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Prostacyclin

Treatment with prostacyclin

Group Type EXPERIMENTAL

Prostacycline

Intervention Type DRUG

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

Isotonic saline

Treatment with isotonic saline

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

same volume as the group that are allocated to prostacycline

Interventions

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Prostacycline

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

Intervention Type DRUG

Isotonic saline

same volume as the group that are allocated to prostacycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Pär Johansson

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pär Johansson I Johansson, MD DMSc MPA

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Rigshospitalet

Copenhagen, Region Sjælland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ET Abdominal

Identifier Type: -

Identifier Source: org_study_id

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