NCT00494949

Brief Summary

The purpose of this study is to evaluate the safety and possible effectiveness of Hemospan solution in patients undergoing elective orthopedic surgery who receive spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

3.3 years

First QC Date

June 28, 2007

Last Update Submit

August 15, 2013

Conditions

HypotensionHypoxia

Keywords

Anesthesia, spinalBlood substitutesOxygen therapeuticsOrthopedic surgeryPlasma expandersVasoconstrictionHemospan

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    21 days

Secondary Outcomes (9)

  • Changes from baseline in pulse oximetry

    4 days

  • Change in Arterial blood gas and blood lactate levels from baseline

    4 days

  • Duration of supplemental inspired oxygen [FIO2]

    4 days

  • Number and duration of intra-operative hypotensive episodes (SBP<90 mmHg or a DBP <50 mmHg)

    4 days

  • Incidence of pharmacologic intervention for hypotension

    4 days

  • +4 more secondary outcomes

Study Arms (2)

Hemospan (MP4OX)

EXPERIMENTAL

4.3 g/dL MalPEG-Hb solution

Drug: Hemospan (MP4OX)

Control

ACTIVE COMPARATOR

Ringer's lactate

Drug: Ringer's lactate

Interventions

Hemospan (MP4OX)DRUG

200, 400, 600, 750, or 1000 mL of Hemospan (MP4OX)

Also known as: MP4OX solution, 4.3 g/dL MalPEG-Hb, PEGylated Hb
Hemospan (MP4OX)
Ringer's lactateDRUG

200, 400, 600, 750, or 1000 mL of Ringer's lactate solution

Also known as: Lactated Ringers, Ringers solution, Hartmann's solution
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult male or postmenopausal female(last menses at least 12 months prior and laboratory assessment verifying appropriate FSH and LH levels \[laboratory assessments not necessary if last menses at least 12 months prior\]), American Society of Anesthesiologists classification system (ASA) class I or II patients over the age of 18 scheduled for orthopedic surgery with spinal anesthesia
  • Patients have to be in good health (other than the orthopedic indication for surgery) as determined by medical history, physical examination, clinical laboratory studies and ECG, all within four weeks prior to drug administration
  • At screening (within four weeks prior to drug administration) the iohexol clearance, urinalysis and hematology (hemoglobin, hematocrit, RBC, WBC, platelets, reticulocytes percentage), PT, PTT had to be within the laboratory normal limits, If a clinical laboratory value (Na, K, albumin, serum creatinine, urea, bilirubin, AST, ALT, ALP, GGT, LDH, conjugated bilirubin, lipase, amylase, total protein, C1, Ca, CK, CK-MB, troponin, cholesterol, glucose, β-2 microglobulin, NAG, osmolarity) is outside the normal range the laboratory test can be repeated. A patient with two consecutive abnormal values is not allowed to participate in the study unless the PI determines the change is not clinically significant. A notation of "Not clinically significant (NCS)" is noted on the laboratory record in that case.
  • Patients have to sign an informed consent form for the study, which is reviewed and approved by the IECs of the Karolinska Hospital or the Stockholm Söder Hospital

You may not qualify if:

  • Any acute or chronic condition which limits the patient's ability to complete the study or jeopardizes the safety of the patient
  • Patients with a history, or clinical manifestation of significant metabolic disorders, cardiovascular disorders (including arrhythmia, tachycardia, hypertension, angina pectoris, chronic heart failure) or psychiatric disorders
  • Patients with a history of chronic hepatic or renal disease
  • Pregnancy
  • Patients who have received any other investigational drugs within 30 days prior to administration of the study drug
  • Patients who test positive to human immunodeficiency virus (HIV), hepatitis B or hepatitis C screens or have any other chronic infection
  • Professional or ancillary personnel involved with the study
  • Presence of a hemoglobinopathy
  • Known allergy to iodine-containing intravenous contrast material or seafood
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Orthopedics, Karolinska Hospital

Stockholm, SE-171 76, Sweden

Location

Department of Orthopedics, Stockholm Söder Hospital

Stockholm, SE-171 76, Sweden

Location

Related Publications (3)

  • Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.

    PMID: 15820947BACKGROUND

  • Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.

    PMID: 17198847BACKGROUND

  • Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.

    PMID: 17122578RESULT

Related Links

MeSH Terms

Conditions

HypotensionHypoxia

Interventions

maleimide-polyethylene glycol-modified hemoglobin, MP4Ringer's LactateRinger's Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Christina I. Olofsson, MD, PhD

    Karolinska University Hospital, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

April 1, 2003

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

SE(2)