Hemostatic Effect of Various Colloid Solutions

Hemostatic Effect of Various Colloid Solutions According to Blood Types

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518544

Enrollment

Unknown

Registered

2007-08-20

Start date

2007-07-31

Completion date

Unknown

Last updated

2007-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laminectomy

Keywords

hydroxyethyl starch, blood type, coagulation

Brief 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. 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).

Interventions

DRUGadministration of hydroxyehtyl starch

colloid is administered during operation according to blood loss.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Blood loss, coagulation and metabolic profiles	pre-infusion, 5 min after infusion, 4 hrs after infusion

Countries

South Korea

Contacts

Primary ContactHyun Joo Ahn, MD., PhD.

hjahn@smc.samsung.co.kr82-2-3410-0784

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026