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Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)

NCT ID: NCT01714297

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.

Detailed Description

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Conditions

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Arthritis of the Hip Transfusion Related Complications Infection Wound Discharge

Keywords

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cemented total hip arthroplasty blood loss wound discharge thromboprophylaxis biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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dalteparin 5000IU s.c.

5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty

Group Type ACTIVE_COMPARATOR

dalteparin 5000 IU s.c.

Intervention Type DRUG

All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.

saline

Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days

Group Type PLACEBO_COMPARATOR

dalteparin 5000 IU s.c.

Intervention Type DRUG

All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.

Interventions

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dalteparin 5000 IU s.c.

All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.

Intervention Type DRUG

Other Intervention Names

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Fragmin

Eligibility Criteria

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Inclusion Criteria

-patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis

Exclusion Criteria

* allergy to Low-Molecular-Weight -Heparin
* bleeding disorders
* renal failure
* hepatic disease
* active treatment for malignancy
* history of deep venous thrombosis or pulmonary embolism
* major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Martina Hansen's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pål Borgen, MD

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olav Reikeras, MD, Phd

Role: STUDY_CHAIR

Oslo University Hospital

Locations

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Martina Hansen's Hospital

Sandvika, Gjettum, Norway

Site Status

Countries

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Norway

References

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Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.

Reference Type RESULT
PMID: 22476844 (View on PubMed)

Other Identifiers

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REK Sør-øst s-08012d

Identifier Type: -

Identifier Source: org_study_id