Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Pål Borgen, MD, Martina Hansen's Hospital
ClinicalTrials.gov Identifier:
NCT01714297
First received: October 23, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Arthritis of the Hip
Transfusion Related Complications
Infection
Wound Discharge
 Drug: dalteparin 5000 IU s.c.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Martina Hansen's Hospital:

Primary Outcome Measures:
  • total blood loss [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    measured blood loss during surgery and in wound drains


Secondary Outcome Measures:
  • transfusion requirements [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    number of units packed red blood cells

  • incidence of bleeding events [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    excessive bleeding, wound hematoma, wound secretion, other bleeding events

  • other complications [ Time Frame: during and after surgery ] [ Designated as safety issue: Yes ]
    all other complications related to surgery


Enrollment: 80
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dalteparin 5000IU s.c.
5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
 Drug: 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.
Other Name: Fragmin
Placebo Comparator: 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
 Drug: 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.
Other Name: Fragmin

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714297

Locations
Norway
Martina Hansen's Hospital
Sandvika, Gjettum, Norway, 1346
Sponsors and Collaborators
Martina Hansen's Hospital
Oslo University Hospital
Investigators
Study Chair: Olav Reikeras, MD, Phd Oslo University Hospital
  More Information

Publications:

Responsible Party: Pål Borgen, MD, MD., Martina Hansen's Hospital
ClinicalTrials.gov Identifier: NCT01714297     History of Changes
Other Study ID Numbers: REK Sør-øst s-08012d
Study First Received: October 23, 2012
Last Updated: December 7, 2012
Health Authority: Norway: Directorate of Health
Norway: Regional Ethics Commitee

Keywords provided by Martina Hansen's Hospital:
cemented total hip arthroplasty
blood loss
wound discharge
thromboprophylaxis
biomarkers

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013