CoagulopathyNCT06683079
Comparison Between Colloids and Crystalloids on Coagulation and Blood Loss
An observational study of Coagulopathy, run by Assiut University at 1 site in Egypt.
Trial summary
Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coagulopathy
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2017to 1 Nov 2019
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient undergoing elective colorectal surgery
Who may be able to join
- age between 18 to 75 years
- undergoing elective colorectal surgery
Who cannot join
- refusal by the patient
- patient with cardiac disease
- hepatic disease
- renal disease
- blood disease
- patient on regular anticoagulant drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Hydroxyethyl Starch and Ringer's Lactate on Blood Loss and Coagulation After Colorectal Surgery.
Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids.
Ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before Ringer's.
Read more
Voluven (Hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion.
The effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode.
The amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.
Read the detailed description
When considering the optimum fluid of choice to achieve hemodynamic stability and the least morbidity, colloids have a theoritical and intuitive advantage. Being composed of molecules >35 kDa, colloids have traditionally been thought to have greater fluid efficacy (i.e. they remain in the intravascular space for longer ,thus contributing a greater effect on cardiac output) compared with crystalloids. These theoritical benefits of colloids led to their routine use in goal-directed therapy (GDT).
Studies in healthy volunteers have demonstrated that crystalloids tend to expand the intravascular volume by about 20% of the infused volume ;however when physiological endpoints have been used in clinical studies , the fluid efficacy of crystalloids increases up to 60%. This discrepancy may be explained by a number of factors, including the time taken for fluid to equilibrate throughout the extracellular fluid , the vaodilating effect of anethetic-indused hypotension on vascular capacitance, and the impairment of fluid elimination because of the surgical stress response.
While colloid has been the default fluid choice in most GDT studies to date, recent evidence from both the perioperative anesthestic setting and from intensive care have raised concerns that these agents may produce adverse effects on renal function and coagulation . recent studies have sought to compare the use of crystalloid solutions with colloids for GDT.
- Conditions
- Coagulopathy
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colloid group | recieve colloids as a maintenance intraoperative fluid . | |
| crystalloid group | recieve crystalloids as a maintenance intraoperative fluid . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prothrombin Time (PT) Measurement
Measurement of Prothrombin Time to assess the effect of colloid and crystalloid administration on clotting time. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: Baseline just after induction, at end of infusion, and 6 hours post-operative.
International Normalized Ratio (INR)
Calculation of International Normalized Ratio to standardize clotting time measurements and evaluate the effect of fluid type on coagulation. Unit of Measure: ratio. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: baseline just after induction, at end of infusion, 6 hours post-operative.
Activated Partial Thromboplastin Time (aPTT)
Measurement of Activated Partial Thromboplastin Time to assess the intrinsic coagulation pathway after administration of colloid or crystalloid. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: baseline just after induction, at end of infusion, 6 hours post-operative.
Factor V Levels
Measurement of plasma levels of coagulation Factor V to evaluate changes in coagulation function following fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: baseline just after induction, at end of infusion, 6 hours post-operative.
Factor VIII Levels
Plasma level measurement of coagulation Factor VIII to assess the impact of colloid and crystalloid on coagulation. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: Baseline just after induction, at end of infusion, 6 hours post-operative.
Factor IX Levels
Measurement of coagulation Factor IX levels in plasma to assess any changes in the clotting profile after fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Measured: Baseline just after induction, at end of infusion, 6 hours post-operative.
Blood Loss Volume
Measurement of total blood loss volume to compare the effects of colloid and crystalloid solutions on hemostasis. Blood loss is calculated using the method outlined by Choi et al. (2010), which includes the volume in suction (minus irrigation fluid), visible blood on the surgical field, and blood absorbed in surgical pads. Surgical pads are estimated by inspection, with fully soaked pads counted as 150 mL and half-soaked pads as 100 mL. Unit of Measure: milliliters (mL).
Measured: Total volume recorded at the end of the surgical procedure.
Secondary outcomes (1)
Blood transfusion requirements
Assessment of the need for blood transfusions following administration of colloid or crystalloid solutions, to evaluate the effect of each solution on blood loss and hemostasis. Unit of Measure: number of transfusion units administered.
Measured: Total units required recorded at the end of the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Sep 2017
- Primary completion1 Sep 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Usama Mohammed Rabie, Assiut University
- Investigators
- Kilany Ali Abdelsalam, Principal investigator, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683079
- Sponsor's protocol ID
- colloids versus crystalloids
- Status last verified
- Nov 2024
- First submitted
- 25 Jul 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Hydroxyethyl Starch and Ringer's Lactate on Blood Loss and Coagulation After Colorectal Surgery.
- ClinicalTrials.gov ID
- NCT06683079
- Acronym / sponsor ID
- colloids versus crystalloids
- Conditions
- Coagulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 12 Nov 2024 (actual)
- 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.
Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids.
Ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before Ringer's.
Voluven (Hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion.
The effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode.
The amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.
Detailed description
When considering the optimum fluid of choice to achieve hemodynamic stability and the least morbidity, colloids have a theoritical and intuitive advantage. Being composed of molecules >35 kDa, colloids have traditionally been thought to have greater fluid efficacy (i.e. they remain in the intravascular space for longer ,thus contributing a greater effect on cardiac output) compared with crystalloids. These theoritical benefits of colloids led to their routine use in goal-directed therapy (GDT).
Studies in healthy volunteers have demonstrated that crystalloids tend to expand the intravascular volume by about 20% of the infused volume ;however when physiological endpoints have been used in clinical studies , the fluid efficacy of crystalloids increases up to 60%. This discrepancy may be explained by a number of factors, including the time taken for fluid to equilibrate throughout the extracellular fluid , the vaodilating effect of anethetic-indused hypotension on vascular capacitance, and the impairment of fluid elimination because of the surgical stress response.
While colloid has been the default fluid choice in most GDT studies to date, recent evidence from both the perioperative anesthestic setting and from intensive care have raised concerns that these agents may produce adverse effects on renal function and coagulation . recent studies have sought to compare the use of crystalloid solutions with colloids for GDT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colloid group | – | –recieve colloids as a maintenance intraoperative fluid . |
| crystalloid group | – | –recieve crystalloids as a maintenance intraoperative fluid . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient undergoing elective colorectal surgery
Key inclusion criteria (2 listed)
- age between 18 to 75 years
- undergoing elective colorectal surgery
Key exclusion criteria (6 listed)
- refusal by the patient
- patient with cardiac disease
- hepatic disease
- renal disease
- blood disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prothrombin Time (PT) Measurement
Time frame: Baseline just after induction, at end of infusion, and 6 hours post-operative.
Measurement of Prothrombin Time to assess the effect of colloid and crystalloid administration on clotting time. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
International Normalized Ratio (INR)
Time frame: baseline just after induction, at end of infusion, 6 hours post-operative.
Calculation of International Normalized Ratio to standardize clotting time measurements and evaluate the effect of fluid type on coagulation. Unit of Measure: ratio. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Activated Partial Thromboplastin Time (aPTT)
Time frame: baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of Activated Partial Thromboplastin Time to assess the intrinsic coagulation pathway after administration of colloid or crystalloid. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor V Levels
Time frame: baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of plasma levels of coagulation Factor V to evaluate changes in coagulation function following fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor VIII Levels
Time frame: Baseline just after induction, at end of infusion, 6 hours post-operative.
Plasma level measurement of coagulation Factor VIII to assess the impact of colloid and crystalloid on coagulation. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Factor IX Levels
Time frame: Baseline just after induction, at end of infusion, 6 hours post-operative.
Measurement of coagulation Factor IX levels in plasma to assess any changes in the clotting profile after fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.
Blood Loss Volume
Time frame: Total volume recorded at the end of the surgical procedure.
Measurement of total blood loss volume to compare the effects of colloid and crystalloid solutions on hemostasis. Blood loss is calculated using the method outlined by Choi et al. (2010), which includes the volume in suction (minus irrigation fluid), visible blood on the surgical field, and blood absorbed in surgical pads. Surgical pads are estimated by inspection, with fully soaked pads counted as 150 mL and half-soaked pads as 100 mL. Unit of Measure: milliliters (mL).
1 secondary outcome
Blood transfusion requirements
Time frame: Total units required recorded at the end of the surgical procedure.
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Kilany Ali Abdelsalam principal investigator
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, run by Assiut University at 1 site in Egypt.
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 2 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 12 Nov 2024. 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 Egypt. 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. 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?
Prothrombin Time (PT) Measurement (time frame: Baseline just after induction, at end of infusion, and 6 hours post-operative.). The study lists 7 primary outcomes in all. 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 12 Nov 2024.