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

Primary Purpose

Arthritis of the Hip, Transfusion Related Complications, Infection

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
dalteparin 5000 IU s.c.
Sponsored by
Martina Hansen's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthritis of the Hip focused on measuring cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Martina Hansen's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dalteparin 5000IU s.c.

saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

total blood loss
measured blood loss during surgery and in wound drains

Secondary Outcome Measures

transfusion requirements
number of units packed red blood cells
incidence of bleeding events
excessive bleeding, wound hematoma, wound secretion, other bleeding events
other complications
all other complications related to surgery

Full Information

First Posted
October 23, 2012
Last Updated
December 7, 2012
Sponsor
Martina Hansen's Hospital
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01714297
Brief Title
Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)
Official Title
A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martina Hansen's Hospital
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of the Hip, Transfusion Related Complications, Infection, Wound Discharge
Keywords
cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dalteparin 5000IU s.c.
Arm Type
Active Comparator
Arm Description
5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
dalteparin 5000 IU s.c.
Other Intervention Name(s)
Fragmin
Intervention Description
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.
Primary Outcome Measure Information:
Title
total blood loss
Description
measured blood loss during surgery and in wound drains
Time Frame
during and after surgery
Secondary Outcome Measure Information:
Title
transfusion requirements
Description
number of units packed red blood cells
Time Frame
during and after surgery
Title
incidence of bleeding events
Description
excessive bleeding, wound hematoma, wound secretion, other bleeding events
Time Frame
during and after surgery
Title
other complications
Description
all other complications related to surgery
Time Frame
during and after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Reikeras, MD, Phd
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Martina Hansen's Hospital
City
Sandvika
State/Province
Gjettum
ZIP/Postal Code
1346
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22476844
Citation
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.
Results Reference
result

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

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