Clinical Trial Results:
The effect of prostacyclin on haemostasis as evaluated by thrombelastography and endothelial markers in patients undergoing major abdominal surgery. A pilot study.
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Summary
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EudraCT number |
2011-005234-19 |
Trial protocol |
DK |
Global end of trial date |
25 Jan 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
28 May 2022
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First version publication date |
28 May 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ET_Abdominal
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, DK-2100
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Public contact |
Pär Ingemar Johansson, MD, Rigshospitalet, Transfusion Medicines Unit, Capital Blood Bank 2034, +45 35452030, per.johansson@regionh.dk
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Scientific contact |
Pär Ingemar Johansson, MD, Rigshospitalet, Transfusion Medicines Unit, Capital Blood Bank 2034, +45 35452030, per.johansson@regionh.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
25 Jan 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jan 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the effect of continues prostacyclin infusion in patient undergoing major abdominal surgery. Main endpoint is change in concentration of endothelial activation markers from baseline to discharger from postoperative ward or 24 hours postoperatively, whichever comes first.
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Protection of trial subjects |
Patients included in this trial is admitted to the hospital undergoing surgery and will be closely monitored according to standard practice at all time.
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Background therapy |
Standard of care | ||
Evidence for comparator |
Isotonic water is chosen as comparator in this trial to reflect standard of care | ||
Actual start date of recruitment |
01 Feb 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients are only recriuted at Rigshospitalet undergoing abdominal surgery. Informed consent will be collected before inklusion in the trial. patients are recruited in a period from October 2013 to February 2014 | |||||||||
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Pre-assignment
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Screening details |
Patients undergoing abdominal surgery(pancreaticoduodenectomy) are subject for screening. All patients must be 18 years old or above. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Data analyst | |||||||||
Blinding implementation details |
Patients were randomized to either prostacyclin or placebo 8saline). Both are colorless fluid and it’s not possible to distinct those from each other. The infusion is given in a blinded manner, thus either the patient or the treating physician know what the patients receive.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention arm | |||||||||
Arm description |
patients in this arm receive prostacyclin (Ilomedin) infusion | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Ilomedin
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Investigational medicinal product code |
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Other name |
Prostacyclin
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Prostacyclin infusion is given at a dose at 1 ng/kg/min from start of surgery until 6 hours postoperatively.
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Arm title
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Placebo arm | |||||||||
Arm description |
This arn is isotonic saline given as placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Isotonic saline
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Investigational medicinal product code |
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Other name |
NaCl 0.9%
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
Prostacyclin infusion is given at a dose at 1 ng/kg/min from start of surgery until 6 hours postoperatively.
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Baseline characteristics reporting groups
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Reporting group title |
Intervention arm
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Reporting group description |
patients in this arm receive prostacyclin (Ilomedin) infusion | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo arm
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Reporting group description |
This arn is isotonic saline given as placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention arm
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Reporting group description |
patients in this arm receive prostacyclin (Ilomedin) infusion | ||
Reporting group title |
Placebo arm
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Reporting group description |
This arn is isotonic saline given as placebo | ||
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End point title |
Trombomodulin | |||||||||||||||
End point description |
The data reflects the difference between the groups, indication that souble trombomodulin increased more in the placebo group than the intervention group
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End point type |
Primary
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End point timeframe |
FRom start of surgery until 6 hours post surgery.
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Statistical analysis title |
Primary endpoint | |||||||||||||||
Comparison groups |
Placebo arm v Intervention arm
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||||||||
P-value |
< 0.05 | |||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||||||||
Parameter type |
Median difference (final values) | |||||||||||||||
Confidence interval |
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End point title |
Transfusion requirements | |||||||||||||||
End point description |
The data reflects the difference between the groups, indicating that the placebo group received more red blood cells than the intervantion group
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End point type |
Secondary
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End point timeframe |
From start of surgery until 6 hours post surgery
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| No statistical analyses for this end point | ||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events were reported from start of surgery to 12 hours post surgery.
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Adverse event reporting additional description |
All AE and SAE will be recorded in the patients electronic hospital file, however only AR and SAR will be recorded in the patient CRF.
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
None | ||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Overall trail
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Reporting group description |
No AE is recorded | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: As these pateints are severily ill, AE are not recorded as seperate AE but as part of the patients regular medical chart. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/27926661 |
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