Hemorrhage, SurgicalGelaringNCT02461329
Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy
A study testing Gelofusine® B. Braun and Ringerfundin ® B. Braun in people with Hemorrhage, Surgical and Hip Replacement, Total, run by Kratochvil Milan, MD.
Trial summary
The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Hemorrhage, Surgical, Hip Replacement, Total, Thrombocytopathy
- What is being tested?
- Gelofusine® B. Braun and Ringerfundin ® B. Braun
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for elective hip replacement surgery
- age between 19-85 years
- signed informed consent
Who cannot join
- informed consent not signed
- traumatic hip fracture
- anemia (hemoglobin level < 100 g/l)
- allergy to study drug and/or multiple allergies
- chronic heart failure with LVEF < 30%
- shock states
Show all 11Show fewer
- coagulopathy
- thrombocytopenia
- thrombocytopathy
- chronic kidney disease with oliguria
- chronic antiplatelet drug medications
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Gelatine (Gelofusine ® B. Braun) Versus Crystalloid Solution (Ringerfundin ® B. Braun) for Volume Therapy on Coagulation, Thrombocyte Function and Thrombelastometry (ROTEM ®), in Elective Hip Replacement Surgery
The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).
Read the detailed description
After obtaining the research ethics committee approval, 50 patients, undergoing elective surgery for hip replacement will be included. The informed consent must be signed prior to randomization. After arriving to the operation theatre, the patients informed consent and inclusion and exclusion criteria will be reviewed. Afterwards, the patients will be randomized in one of two groups. Prior to the anaesthesia induction, blood for the thrombocyte function test, coagulation tests and thrombelastometry wil be drawn via a metal cannula. A large bore peripheral venous cannula (G18 or more) will be introduced. In case of a ASA status of III and higher based on cardiovascular morbidity an arterial catheter via the radial artery for invasive blood pressure monitoring will be introduced. Urinary catheter will be introduced to monitor intraoperative diuresis. A continuous crystalloid infusion n a dose of 5 ml/kg/hour will be administered for basal fluid substitution. The volume replacement using blinded gelatine/crystalloid solution will be performed via fluid challenge (repeated 250 ml fluid boluses during a 5 minute interval) to hemodynamic targets (increase in blood pressure, decrease in heart rate), in case of a decrease of MAP to 65 mm Hg (16) or to 70 mmHg in preexisting hypertension. The hemodynamic variables before and after fluid challenge will be exactly recorded. In case the patient hemodynamics does dot respond to a fluid challenge, or in case of a drop of blood pressure to less than 55 mmHg, a bolus of 5-10 mg of ephedrine (repeatedly) will be administered. Further recorded variables will be: blood loss (suctioning, sponges), diuresis, number of transfusions administered. Repetitive hemoglobin concentration tests using the HemoCue 201+ device will be performed and an intraoperative blood transfusion trigger of 90 g/l of hemoglobin concentration will be used, 100 g/l in case of a patient with chronic cardiovascular or respiratory disease (5). After reaching the blood loss of 1000 ml, blood samples will be drawn for laboratory hemoglobin concentration and coagulation testing. The trigger for platelet transfusion will be a thrombocyte count of less than 50000 x 109, or sings of platelet dysfunction on thrombelastometry. Tranexamic acid will be administered in case of signs of fibrinolysis on thrombelastometry or in case of life threatening bleeding. At the end of surgery, a second blood sample for platelet function test, thrombelastometry, full blood count and standard coagulation tests will be drawn. The amount of blinded study infusion, continuous crystalloid solution, transfusions and ephedrine administered, diuresis and blood loss will be recorded. Blood urea and creatinine, diuresis, coagulations and full blood count will be recorded postoperatively. Hospital and ICU length of stay, hospital and 90-day mortality will be followed.
- Being tested
- Gelofusine® B. Braun, Ringerfundin ® B. Braun
- Keywords
- Hip Replacement, Total, Gelatine solution, Balanced Crystaloid Solution, Volume therapy, Platelet aggregation
- Medical subject headings
- Blood Loss, Surgical, Blood Platelet Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelofusine® B. BraunDrug
Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets
Ringerfundin ® B. BraunDrug
Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets
| Study group | Role | What they receive |
|---|---|---|
| Gelatine solution | Experimental | Gelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease).
The blood pressure and heart rate before and after fluid challenge will be recorded. Receives: Drug: Gelofusine® B. Braun |
| Balanced Crystaloid solution | Experimental | Ringerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease).
The blood pressure and heart rate before and after fluid challenge will be recorded. Receives: Drug: Ringerfundin ® B. Braun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of coagulation status and platelet function
Before and after the surgery (in OR) the investigator will obtain a blood sample from subject, standard coagulation test will be performed (INR, PT, aPTT, thrombin time), the investigator will perform ROTEM tests: EXTEM, INTEM and FIBTEM assay and blood sample will be tested for thrombocyte function - aggregation with ADP, collagen, epinephrine, TRAP - thrombin receptor-activated peptide.
Measured: perioperative, an expected average of 2 hours
Secondary outcomes (3)
Blood loss
Amount of blood loss during the surgery and in the postoperative period
Measured: perioperative, an expected average of 2 hours
Renal function
serum creatinine and blood urea nitrogen will be recorded 48 hours after surgery
Measured: 2 days after surgery
Transfusion needs
Number of transfusion units administered during whole hospital stay
Measured: hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage, SurgicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kratochvil Milan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- IBA - Masaryk University Institute of biostatistics and analyses
- Responsible party
- Sponsor-investigator, Kratochvil Milan, MD, Brno University Hospital
- Investigators
- Milan Kratochvil, MD, Principal investigator, FN BrnoMilan Kratochvil, MD, Study director, FN BrnoRoman Gál, Prof, MD, Ph.D, Study chair, Fn Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461329
- Sponsor's protocol ID
- FN-Brno
- Acronym
- Gelaring
- Status last verified
- Jun 2015
- First submitted
- 16 Apr 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Gelatine (Gelofusine ® B. Braun) Versus Crystalloid Solution (Ringerfundin ® B. Braun) for Volume Therapy on Coagulation, Thrombocyte Function and Thrombelastometry (ROTEM ®), in Elective Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT02461329
- Acronym / sponsor ID
- Gelaring / FN-Brno
- Keywords
- Hip Replacement, Total, Gelatine solution, Balanced Crystaloid Solution, Volume therapy, Platelet aggregation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kratochvil Milan, MDUniversity, hospital or other
- Collaborators
- IBA - Masaryk University Institute of biostatistics and analyses
- Study start
- May 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 Jun 2015 (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 the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).
Detailed description
After obtaining the research ethics committee approval, 50 patients, undergoing elective surgery for hip replacement will be included. The informed consent must be signed prior to randomization. After arriving to the operation theatre, the patients informed consent and inclusion and exclusion criteria will be reviewed. Afterwards, the patients will be randomized in one of two groups. Prior to the anaesthesia induction, blood for the thrombocyte function test, coagulation tests and thrombelastometry wil be drawn via a metal cannula. A large bore peripheral venous cannula (G18 or more) will be introduced. In case of a ASA status of III and higher based on cardiovascular morbidity an arterial catheter via the radial artery for invasive blood pressure monitoring will be introduced. Urinary catheter will be introduced to monitor intraoperative diuresis. A continuous crystalloid infusion n a dose of 5 ml/kg/hour will be administered for basal fluid substitution. The volume replacement using blinded gelatine/crystalloid solution will be performed via fluid challenge (repeated 250 ml fluid boluses during a 5 minute interval) to hemodynamic targets (increase in blood pressure, decrease in heart rate), in case of a decrease of MAP to 65 mm Hg (16) or to 70 mmHg in preexisting hypertension. The hemodynamic variables before and after fluid challenge will be exactly recorded. In case the patient hemodynamics does dot respond to a fluid challenge, or in case of a drop of blood pressure to less than 55 mmHg, a bolus of 5-10 mg of ephedrine (repeatedly) will be administered. Further recorded variables will be: blood loss (suctioning, sponges), diuresis, number of transfusions administered. Repetitive hemoglobin concentration tests using the HemoCue 201+ device will be performed and an intraoperative blood transfusion trigger of 90 g/l of hemoglobin concentration will be used, 100 g/l in case of a patient with chronic cardiovascular or respiratory disease (5). After reaching the blood loss of 1000 ml, blood samples will be drawn for laboratory hemoglobin concentration and coagulation testing. The trigger for platelet transfusion will be a thrombocyte count of less than 50000 x 109, or sings of platelet dysfunction on thrombelastometry. Tranexamic acid will be administered in case of signs of fibrinolysis on thrombelastometry or in case of life threatening bleeding. At the end of surgery, a second blood sample for platelet function test, thrombelastometry, full blood count and standard coagulation tests will be drawn. The amount of blinded study infusion, continuous crystalloid solution, transfusions and ephedrine administered, diuresis and blood loss will be recorded. Blood urea and creatinine, diuresis, coagulations and full blood count will be recorded postoperatively. Hospital and ICU length of stay, hospital and 90-day mortality will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatine solution | Experimental | Drug: Gelofusine® B. BraunGelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded. |
| Balanced Crystaloid solution | Experimental | Drug: Ringerfundin ® B. BraunRingerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease). The blood pressure and heart rate before and after fluid challenge will be recorded. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient scheduled for elective hip replacement surgery
- age between 19-85 years
- signed informed consent
Key exclusion criteria (11 listed)
- informed consent not signed
- traumatic hip fracture
- anemia (hemoglobin level < 100 g/l)
- allergy to study drug and/or multiple allergies
- chronic heart failure with LVEF < 30%
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 |
|---|---|---|
| Gelofusine® B. BraunVolume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets | Drug | Gelatine solution |
| Ringerfundin ® B. BraunVolume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets | Drug | Balanced Crystaloid solution |
Primary outcome
Change of coagulation status and platelet function
Time frame: perioperative, an expected average of 2 hours
Before and after the surgery (in OR) the investigator will obtain a blood sample from subject, standard coagulation test will be performed (INR, PT, aPTT, thrombin time), the investigator will perform ROTEM tests: EXTEM, INTEM and FIBTEM assay and blood sample will be tested for thrombocyte function - aggregation with ADP, collagen, epinephrine, TRAP - thrombin receptor-activated peptide.
3 secondary outcomes
Blood loss
Time frame: perioperative, an expected average of 2 hours
Renal function
Time frame: 2 days after surgery
Transfusion needs
Time frame: hospital stay, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Milan Kratochvil, MD principal investigator
FN Brno
Milan Kratochvil, MD study director
FN Brno
Roman Gál, Prof, MD, Ph.D study chair
Fn Brno
Questions about this trial
What is this clinical trial studying?
A study testing Gelofusine® B. Braun and Ringerfundin ® B. Braun in people with Hemorrhage, Surgical and Hip Replacement, Total, run by Kratochvil Milan, MD.
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 11 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 3 Jun 2015. 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.
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 Milan Kratochvil, MD (+420532232009, mkratochvil@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of coagulation status and platelet function (time frame: perioperative, an expected average of 2 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 3 Jun 2015.