Disorders of CoagulationPhase 4NCT02009033
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
A Phase 4 study testing Lactated Ringer and Hydroxyethylstarch in people with Disorders of Coagulation, run by K. C. Rasmussen.
Trial summary
The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorders of Coagulation
- What is being tested?
- Lactated Ringer and Hydroxyethylstarch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 4
- 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
- Patient older than 18 years.
- Indication for elective surgery with removal of the urine bladder.
- Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.
Who cannot join
- Cerebral haemorrhage
- Renal insufficiency demanding dialysis
- Manifest cardiac and hepatic insufficiency
- Disturbance in coagulation
- Hypernatriæmi
- Hyperchloræmi
Show all 10Show fewer
- Pregnant or nursing
- Allergic to hydroxyethylstarch
- Participating in another trial-if interferring the present trial
- Incapable of managing his own affairs.
About this study
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study
The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.
Read the detailed description
The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.
The secondary goal is to register blood loss and use of blood products during operation.
The trial concerns 40 patients.
- Conditions
- Disorders of Coagulation
- Being tested
- Lactated Ringer, Hydroxyethylstarch
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.
HydroxyethylstarchDrug
| Study group | Role | What they receive |
|---|---|---|
| Ringer's lactate | Experimental | Fluid therapy during operation Receives: Drug: Lactated Ringer; Drug: Hydroxyethylstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate coagulation on basis of bloodsamples
Measured: 6 months
Secondary outcomes (1)
Estimate coagulation by bloodloss and need for transfusion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of CoagulationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- K. C. Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, K. C. Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels Henry Secher, Professor, Study chair, Rigshospitalet , Dept. 2042, 2100 Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009033
- Sponsor's protocol ID
- H-2-2011-063
- Status last verified
- Dec 2013
- First submitted
- 18 Jul 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT02009033
- Acronym / sponsor ID
- H-2-2011-063
- Conditions
- Disorders of Coagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- K. C. RasmussenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2013 (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 thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.
Detailed description
The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.
The secondary goal is to register blood loss and use of blood products during operation.
The trial concerns 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ringer's lactate | Experimental | Drug: Lactated Ringer, Drug: HydroxyethylstarchFluid therapy during operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient older than 18 years.
- Indication for elective surgery with removal of the urine bladder.
- Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.
Key exclusion criteria (10 listed)
- Cerebral haemorrhage
- Renal insufficiency demanding dialysis
- Manifest cardiac and hepatic insufficiency
- Disturbance in coagulation
- Hypernatriæmi
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 |
|---|---|---|
| Lactated RingerWhen normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication. | Drug | Ringer's lactate |
| Hydroxyethylstarch | Drug | Ringer's lactate |
Primary outcome
Estimate coagulation on basis of bloodsamples
Time frame: 6 months
1 secondary outcome
Estimate coagulation by bloodloss and need for transfusion
Time frame: 6 months
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 11 Dec 2013.
Related trials for Disorders of Coagulation
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
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.
Niels Henry Secher, Professor study chair
Rigshospitalet , Dept. 2042, 2100 Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactated Ringer and Hydroxyethylstarch in people with Disorders of Coagulation, run by K. C. Rasmussen.
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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Estimate coagulation on basis of bloodsamples (time frame: 6 months). 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 11 Dec 2013.