BloodlossPhase 4NCT01444508
Effect of Colloid Versus Crystalloid on Coagulation
A Phase 4 study testing Ringer-lactate "SAD" and HES 130/04 in people with Bloodloss, run by K. C. Rasmussen at 1 site in Denmark.
Trial summary
In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodloss
- What is being tested?
- Ringer-lactate "SAD" and HES 130/04
- 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
- 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 more than 18 years old
- Indication for elective post-renal operation including cystectomy
- Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.
Who cannot join
- Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
- Pregnant or nursing
- Allergic
- Disturbance in electrolytes
- Patient under committee
- Patient joining another trial interfering the actual trial.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Niels Henry Secher, Professor, +45 35452242, niels.h.secher@rh.regionh.dk
About this study
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.
- Conditions
- Bloodloss
- Being tested
- Ringer-lactate "SAD", HES 130/04
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer-lactate "SAD"Drug
Also called Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.
Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.
HES 130/04Drug
Also called Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.
Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD".
| Study group | Role | What they receive |
|---|---|---|
| crystalloid | Active comparator | Not described Receives: Drug: Ringer-lactate "SAD" |
| colloid | Placebo comparator | Not described Receives: Drug: HES 130/04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of colloid versus crystalloid on laboratory coagulation.
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on.
The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.
Measured: 5-7 hours
Secondary outcomes (1)
Effect of colloid versus crystalloid on the amount of bloodloss
The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on.
Measured: 5-7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BloodlossStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444508
- Sponsor's protocol ID
- 2011-003270-80
- Status last verified
- Dec 2013
- First submitted
- 10 Sep 2011
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.
PubMed 24100337
Study at a glance
From the registry record, last updated by the sponsor on 13 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
- ClinicalTrials.gov ID
- NCT01444508
- Acronym / sponsor ID
- 2011-003270-80
- Conditions
- Bloodloss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- 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 (estimated)
- First posted
- 30 Sep 2011 (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.
In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crystalloid | Active comparator | Drug: Ringer-lactate "SAD" |
| colloid | Placebo comparator | Drug: HES 130/04 |
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 more than 18 years old
- Indication for elective post-renal operation including cystectomy
- Patient without anticoagulative, acetylsalicylic acid or NSAID treatment for the last 5 days.
Key exclusion criteria (6 listed)
- Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
- Pregnant or nursing
- Allergic
- Disturbance in electrolytes
- Patient under committee
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 |
|---|---|---|
| Ringer-lactate "SAD"Also: Ringer-laktat "SAD", B 05 BB 01, Amgros A/S.Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved. | Drug | crystalloid |
| HES 130/04Also: Voluven, HES 130/04, B 05 AA 07, Fresenius Kabi A/S.Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD". | Drug | colloid |
Primary outcome
Effect of colloid versus crystalloid on laboratory coagulation.
Time frame: 5-7 hours
Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin.
1 secondary outcome
Effect of colloid versus crystalloid on the amount of bloodloss
Time frame: 5-7 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Derived from this study: PubMed 24100337Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer-lactate "SAD" and HES 130/04 in people with Bloodloss, run by K. C. Rasmussen 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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niels H Secher, Professor (+45 3545 2242, nielsh.secher@rh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of colloid versus crystalloid on laboratory coagulation. (time frame: 5-7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444508, which also lists 1 linked publication.
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 13 Dec 2013.