Hemorrhage; Complicating Delivery, Coagulation DefectPhase 4NCT02270723
The Effect of Human Albumin on Coagulation Competence and Hemorrhage
A Phase 4 study testing 5% Human Albumin " Behring" and Lactated Ringer in people with Hemorrhage; Complicating Delivery, Coagulation Defect, run by Kirsten Cleemann Rasmussen at 1 site in Denmark.
Trial summary
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage; Complicating Delivery, Coagulation Defect
- What is being tested?
- 5% Human Albumin " Behring" and Lactated Ringer
- 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
- Aug 2014to Nov 2015
- 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 nonsteroidal antiinflammatory drug
- 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 to Human Albumin
- Disturbance in electrolytes
- Patient under committee
- Patient joining another trial interfering the actual trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
Read the detailed description
5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether affected coagulation competence induced by Human Albumin leads to a significant perioperative blood loss when compared to administration of lactated Ringer´s solution.
Data are gathered by the investigators, analysed by the sponsor, and remain confidential throughout the process. The investigators shall be involved in all stages of the study development and vouch for the completeness and accuracy of the data. No third part shall influence the protocol, trial conduct, data analysis, or reporting.
The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial pressure, cardiac output are measured after induction of anaesthesia and insertion of the arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours thereafter in the recovery room (T4).
Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30) depicting haemostatic competence (thrombelastography). The investigators analyze blood for haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the central venous catheter for lactate and blood gas variables (ABL 825, Radiometer, Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated fluid (non-study fluid).
The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of surgery, and two hours thereafter. The investigators register complications postoperatively inclusive hospital stay until discharge.
- Being tested
- 5% Human Albumin " Behring", Lactated Ringer
- Medical subject headings
- Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Human Albumin " Behring"Drug
Also called Human Albumin
Intravenous infusion of 5% Human Albumin during major surgery
Lactated RingerDrug
Also called Ringer
Intravenous infusion of Lactated Ringer during major surgery
| Study group | Role | What they receive |
|---|---|---|
| Human Albumin " Behring" | Active comparator | Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours Receives: Drug: 5% Human Albumin " Behring" |
| Lactated Ringer | Placebo comparator | Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours Receives: Drug: Lactated Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of coagulation during surgery and in the recovery room
Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude
Measured: up to 1 day after surgery
Secondary outcomes (2)
Measurement of postoperative surgical complications
Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation
Measured: From date of operation up to 1 months postoperatvely
Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room
Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin
Measured: up to 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (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 Hemorrhage; Complicating Delivery, Coagulation DefectStudies 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, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsten Cleemann Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Cleemann Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Niels H Secher, MD PHD Prof, Study chair, Rigshospitalet, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270723
- Sponsor's protocol ID
- COL18
- Status last verified
- Oct 2014
- First submitted
- 27 Sep 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Mar;95(9):e2720. doi: 10.1097/MD.0000000000002720.
PubMed 26945358
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. 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
- NCT02270723
- Acronym / sponsor ID
- COL18
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kirsten Cleemann RasmussenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 21 Oct 2014 (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 a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.
Detailed description
5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether affected coagulation competence induced by Human Albumin leads to a significant perioperative blood loss when compared to administration of lactated Ringer´s solution.
Data are gathered by the investigators, analysed by the sponsor, and remain confidential throughout the process. The investigators shall be involved in all stages of the study development and vouch for the completeness and accuracy of the data. No third part shall influence the protocol, trial conduct, data analysis, or reporting.
The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial pressure, cardiac output are measured after induction of anaesthesia and insertion of the arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours thereafter in the recovery room (T4).
Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30) depicting haemostatic competence (thrombelastography). The investigators analyze blood for haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the central venous catheter for lactate and blood gas variables (ABL 825, Radiometer, Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated fluid (non-study fluid).
The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of surgery, and two hours thereafter. The investigators register complications postoperatively inclusive hospital stay until discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Albumin " Behring" | Active comparator | Drug: 5% Human Albumin " Behring"Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours |
| Lactated Ringer | Placebo comparator | Drug: Lactated RingerInfusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient more than 18 years old
- Indication for elective post-renal operation including cystectomy
- Patient without anticoagulative, acetylsalicylic acid or nonsteroidal antiinflammatory drug
- 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 to Human Albumin
- 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 |
|---|---|---|
| 5% Human Albumin " Behring"Also: Human AlbuminIntravenous infusion of 5% Human Albumin during major surgery | Drug | Human Albumin " Behring" |
| Lactated RingerAlso: RingerIntravenous infusion of Lactated Ringer during major surgery | Drug | Lactated Ringer |
Primary outcome
Measurement of coagulation during surgery and in the recovery room
Time frame: up to 1 day after surgery
Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude
2 secondary outcomes
Measurement of postoperative surgical complications
Time frame: From date of operation up to 1 months postoperatvely
Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room
Time frame: up to 1 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Derived from this study: PubMed 26945358Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Mar;95(9):e2720. doi: 10.1097/MD.0000000000002720.
Related trials for Hemorrhage; Complicating Delivery, Coagulation Defect
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Detection of Bleeding Disorders Diagnosed After Vaginal Delivery Complicated by Severe Postpartum Hemorrhage
Severe Postpartum Hemorrhage
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 H Secher, MD PHD Prof study chair
Rigshospitalet, University of Copenhagen
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 5% Human Albumin " Behring" and Lactated Ringer in people with Hemorrhage; Complicating Delivery, Coagulation Defect, run by Kirsten Cleemann 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 4 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 21 Oct 2014. 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?
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?
Measurement of coagulation during surgery and in the recovery room (time frame: up to 1 day after surgery). 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 NCT02270723, 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 21 Oct 2014.