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

Sponsor

Martina Hansen's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01714297

Collaborator

Oslo University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Fragmin

Arm

Intervention/Treatment

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 Names:

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.

Other Names:

Fragmin

Outcome Measures

Primary Outcome Measures

total blood loss [during and after surgery]
measured blood loss during surgery and in wound drains

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.