Tranexamic Acid in Hip Fracture Patients

NCT ID: NCT01326403

Last Updated: 2012-06-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.

Detailed Description

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1. transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
2. Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
3. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
4. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
5. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

Conditions

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Closed Fracture of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

Patients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.

GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.

Group C - A control group will only receive placebo in the emergency room and in the OR.

GROUP B

Patients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.

GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.

Group C - A control group will only receive placebo in the emergency room and in the OR.

GROUP C

A control group will only receive placebo in the emergency room and in the OR.

Group Type PLACEBO_COMPARATOR

Tranexamic acid

Intervention Type DRUG

GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.

GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.

Group C - A control group will only receive placebo in the emergency room and in the OR.

Interventions

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Tranexamic acid

GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.

GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.

Group C - A control group will only receive placebo in the emergency room and in the OR.

Intervention Type DRUG

Other Intervention Names

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placebo group post injury group preoperative group

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
* Patients mentally capable of giving informed consent.

Exclusion Criteria

1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
2. Patients receiving anticoagulation therapy with Coumadin or Plavix.
3. Pregnancy and breastfeeding females.
4. Previous arterial or venous thrombosis
5. History of seizures.
6. Creatinine \>2.
7. Oestroprogestive therapy.
8. Multiple fractures.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role collaborator

Michal Roll PhD,MBA

OTHER_GOV

Sponsor Role lead

Responsible Party

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Michal Roll PhD,MBA

division of research and development TASMC

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ELI SHTEINBERG, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Facility Contacts

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ELI STEINBERG, MD

Role: primary

0524266346

AMIR SHLAIFER, MD

Role: backup

0527360803

Other Identifiers

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TASMC-11-ES-0129-CTIL

Identifier Type: -

Identifier Source: org_study_id

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