SurgeryPhase 1NCT01528943
Effect of Prostacyclin on Haemostasis in Abdominal Surgery
A Phase 1 study testing Prostacycline and Isotonic saline in people with Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Prostacycline and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women above 18 years old
- Undergoing Whipple surgery or liver resection
- Able and willing to give informed consent
Who cannot join
- 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
Show all 10Show fewer
- Pregnant or breastfeeding
- Participating in another clinical study within the last 30 days
- Liver cirrhosis
- Need for renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study
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.
- Conditions
- Surgery
- Being tested
- Prostacycline, Isotonic saline
- Keywords
- prostacycline, endothel integrity and abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProstacyclineDrug
Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
Isotonic salineDrug
same volume as the group that are allocated to prostacycline
| Study group | Role | What they receive |
|---|---|---|
| Prostacyclin | Experimental | Treatment with prostacyclin Receives: Drug: Prostacycline |
| Isotonic saline | Placebo comparator | Treatment with isotonic saline Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial biomarkers
Measured: Baseline to 6 hours postoperatively
Secondary outcomes (1)
Functional haemostasis evaluated by thrombelastography
Measured: Baseline to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pär Johansson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pär Johansson I Johansson, MD DMSc MPA, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528943
- Sponsor's protocol ID
- ET Abdominal
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2012
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study
- ClinicalTrials.gov ID
- NCT01528943
- Acronym / sponsor ID
- ET Abdominal
- Conditions
- Surgery
- Keywords
- prostacycline, endothel integrity and abdominal surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostacyclin | Experimental | Drug: ProstacyclineTreatment with prostacyclin |
| Isotonic saline | Placebo comparator | Drug: Isotonic salineTreatment with isotonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women above 18 years old
- Undergoing Whipple surgery or liver resection
- Able and willing to give informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstacyclineContinuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min | Drug | Prostacyclin |
| Isotonic salinesame volume as the group that are allocated to prostacycline | Drug | Isotonic saline |
Primary outcome
Change in endothelial biomarkers
Time frame: Baseline to 6 hours postoperatively
1 secondary outcome
Functional haemostasis evaluated by thrombelastography
Time frame: Baseline to 6 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pär Johansson I Johansson, MD DMSc MPA principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prostacycline and Isotonic saline in people with Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial biomarkers (time frame: Baseline to 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.