LaminectomyNCT00518544
Hemostatic Effect of Various Colloid Solutions
A study testing administration of hydroxyehtyl starch in people with Laminectomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laminectomy
- What is being tested?
- administration of hydroxyehtyl starch
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to not given
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.
Who cannot join
- the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin < 12 g/dl, platelet count < 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical center
Seoul, 135-710
Hyun Joo Ahn, MD.,PhD., 82-2-3410-0784, hjahn@smc.samsung.co.kr
About this study
Official title: Hemostatic Effect of Various Colloid Solutions According to Blood Types
Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES.
Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).
- Conditions
- Laminectomy
- Being tested
- administration of hydroxyehtyl starch
- Keywords
- hydroxyethyl starch, blood type, coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of hydroxyehtyl starchDrug
colloid is administered during operation according to blood loss.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss, coagulation and metabolic profiles
Measured: pre-infusion, 5 min after infusion, 4 hrs after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyun Joo Ahn, MD., PhD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518544
- Sponsor's protocol ID
- CRS107-17-1
- Status last verified
- Aug 2007
- First submitted
- 16 Aug 2007
- Last updated
- 20 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Effect of Various Colloid Solutions According to Blood Types
- ClinicalTrials.gov ID
- NCT00518544
- Acronym / sponsor ID
- CRS107-17-1
- Conditions
- Laminectomy
- Keywords
- hydroxyethyl starch, blood type, coagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2007
- First posted
- 20 Aug 2007 (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.
Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES.
Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.
Key exclusion criteria (1 listed)
- the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin < 12 g/dl, platelet count < 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES
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 |
|---|---|---|
| administration of hydroxyehtyl starchcolloid is administered during operation according to blood loss. | Drug | – |
Primary outcome
Blood loss, coagulation and metabolic profiles
Time frame: pre-infusion, 5 min after infusion, 4 hrs after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2007.
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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.
Hyun Joo Ahn, MD., PhD. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of hydroxyehtyl starch in people with Laminectomy, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 20 Aug 2007. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Joo Ahn, MD., PhD. (82-2-3410-0784, hjahn@smc.samsung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss, coagulation and metabolic profiles (time frame: pre-infusion, 5 min after infusion, 4 hrs after infusion). 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 20 Aug 2007; AzTrials last refreshed its copy on 1 Nov 2026.