Hemostatic Effect of Various Colloid Solutions

Laminectomy Clinical Trial

Official title:

Hemostatic Effect of Various Colloid Solutions According to Blood Types

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00518544
• Other study ID #: CRS107-17-1
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2007
• Last updated: August 16, 2007
• Start date: July 2007

Study information

• Verified date: August 2007
• Source: Samsung Medical Center
• Contact: Hyun Joo Ahn, MD., PhD.
• Phone: 82-2-3410-0784
• Email: hjahn[@]smc.samsung.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laminectomy

Intervention

Drug:
• administration of hydroxyehtyl starch
colloid is administered during operation according to blood loss.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss, coagulation and metabolic profiles		pre-infusion, 5 min after infusion, 4 hrs after infusion