Effect of Prostacyclin on Haemostasis in Abdominal Surgery | NCT01528943

Studies
Effect of Prostacyclin on Haemostasis in Abdominal Surgery

NCT01528943

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Mar 10, 2021Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Surgery

Interventions

Prostacycline
Isotonic saline

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Feb 5, 2012

First Submission Date that Met QC Criteria

Feb 7, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2021

Last Update Posted Date

Mar 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostacyclin	Experimental	Treatment with prostacyclin	Drug: Prostacycline
Isotonic saline	Placebo Comparator	Treatment with isotonic saline	Drug: Isotonic saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostacycline	Drug	Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min	Prostacyclin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in endothelial biomarkers		Baseline to 6 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Functional haemostasis evaluated by thrombelastography		Baseline to 6 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pär Johansson I Johansson, MD DMSc MPA	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen	Region Sjælland	2100	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided