Platelet AggregationNCT00763997
Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages
A study testing dipyrone, Ibuprofen and Acetaminophen in people with Platelet Aggregation, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Platelet Aggregation
- What is being tested?
- dipyrone, Ibuprofen and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2004to Dec 2004
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned traumatologic, orthopedic, visceral or plastic surgical procedures
Who cannot join
- Prior intake of drugs with effect on the platelet aggregation
- Patients with diseases of the gastrointestinal systems
- Patients with cardiac or circulatory diseases
- Patients receiving corticoids
- Patients with cold or asthma
- ASA-classification > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation
Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.
- Conditions
- Platelet Aggregation
- Being tested
- dipyrone, Ibuprofen, Acetaminophen, Parecoxib/Valdecoxib, Blood samples
- Keywords
- dipyrone, platelet aggregation, neuraxial blockage, ibuprofen, platelet aggregation under dipyrone compared to ibuprofen, acetaminophen and parecoxib/valdecoxib, neuraxial blockage in patients receiving ibuprofen is critical in special circumstances, but traditionally not fpr dipyrone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dipyroneDrug
Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward
IbuprofenDrug
Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day
AcetaminophenDrug
Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day
AcetaminophenDrug
Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day
Parecoxib/ValdecoxibDrug
40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day
Blood samplesOther
Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dipyrone Receives: Drug: dipyrone; Other: Blood samples |
| 2 | Active comparator | Ibuprofen Receives: Drug: Ibuprofen; Other: Blood samples |
| 3 | Active comparator | Acetaminophen Receives: Drug: Acetaminophen; Other: Blood samples |
| 4 | Placebo comparator | Parecoxib/Valdecoxib Receives: Drug: Parecoxib/Valdecoxib; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses
Measured: 24 hours
Secondary outcomes (1)
Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startFeb 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet AggregationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Matthias Schmauss, MD, Principal investigator, research associate of the Ruhr University BochumChristoph Maier, Professor, Study chair, Leader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763997
- Sponsor's protocol ID
- NRA3480005
- Status last verified
- Sep 2008
- First submitted
- 29 Sep 2008
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation
- ClinicalTrials.gov ID
- NCT00763997
- Acronym / sponsor ID
- NRA3480005
- Conditions
- Platelet Aggregation
- Keywords
- dipyrone, platelet aggregation, neuraxial blockage, ibuprofen, platelet aggregation under dipyrone compared to ibuprofen, acetaminophen and parecoxib/valdecoxib, neuraxial blockage in patients receiving ibuprofen is critical in special circumstances, but traditionally not fpr dipyrone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 1 Oct 2008 (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.
Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: dipyrone, Other: Blood samplesDipyrone |
| 2 | Active comparator | Drug: Ibuprofen, Other: Blood samplesIbuprofen |
| 3 | Active comparator | Drug: Acetaminophen, Other: Blood samplesAcetaminophen |
| 4 | Placebo comparator | Drug: Parecoxib/Valdecoxib, Other: Blood samplesParecoxib/Valdecoxib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned traumatologic, orthopedic, visceral or plastic surgical procedures
Key exclusion criteria (6 listed)
- Prior intake of drugs with effect on the platelet aggregation
- Patients with diseases of the gastrointestinal systems
- Patients with cardiac or circulatory diseases
- Patients receiving corticoids
- Patients with cold or asthma
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 |
|---|---|---|
| dipyroneDipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward | Drug | 1 |
| IbuprofenIbuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day | Drug | 2 |
| AcetaminophenAcetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day | Drug | 3 |
| AcetaminophenAcetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day | Drug | 3 |
| Parecoxib/Valdecoxib40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day | Drug | 4 |
| Blood samplesBlood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake | Other | 1, 2, 3, 4 |
Primary outcome
Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses
Time frame: 24 hours
1 secondary outcome
Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug
Time frame: 4 hours
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 1 Oct 2008.
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Cookies for Platelets
Blood Donation
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.
Matthias Schmauss, MD principal investigator
research associate of the Ruhr University Bochum
Christoph Maier, Professor study chair
Leader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dipyrone, Ibuprofen and Acetaminophen in people with Platelet Aggregation, run by Ruhr University of Bochum at 1 site in Germany.
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 1 inclusion and 6 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 1 Oct 2008. 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 Germany. 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.
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?
Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses (time frame: 24 hours). 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 1 Oct 2008.