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Tranexamic Acid in Hip Fracture Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Michal Roll PhD,MBA
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01326403
First received: March 21, 2011
Last updated: June 6, 2012
Last verified: June 2012
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Purpose
This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.
| Condition | Intervention |
|---|---|
| Closed Fracture of Hip | Drug: Tranexamic acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
| Official Title: | Tranexamic Acid in Hip Fracture Patients |
Resource links provided by NLM:
Further study details as provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- Total amount of blood loss per patient from admission to day 5 post-op [ Time Frame: 5 DAYS ]
Secondary Outcome Measures:
- Number of packed cell transfusion per patient. [ Time Frame: 5 DAYS ]
- Initial functional outcome and feeling of well-being. [ Time Frame: 5 days ]
- thromboembolic events [ Time Frame: 5 days ]
- post-operative bacterial infection [ Time Frame: 5 days ]
- 30 day mortality rate [ Time Frame: 30 days ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: 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. Other Names:
|
|
Experimental: 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.
|
Drug: 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. Other Names:
|
|
Placebo Comparator: GROUP C
A control group will only receive placebo in the emergency room and in the OR.
|
Drug: 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. Other Names:
|
Detailed Description:
- transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
- Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
- Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
- in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
- Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
- Patients receiving anticoagulation therapy with Coumadin or Plavix.
- Pregnancy and breastfeeding females.
- Previous arterial or venous thrombosis
- History of seizures.
- Creatinine >2.
- Oestroprogestive therapy.
- Multiple fractures.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01326403
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326403
Locations
| Israel | |
| Sourasky Medical Center | Not yet recruiting |
| Tel Aviv, Israel | |
| Contact: ELI STEINBERG, MD 0524266346 STEINBERGE@TASMC.HEALTH.GOV.IL | |
| Contact: AMIR SHLAIFER, MD 0527360803 SHLAIFER.MD@GMAIL.COM | |
Sponsors and Collaborators
Michal Roll PhD,MBA
Tel-Aviv Sourasky Medical Center
Investigators
| Principal Investigator: | ELI SHTEINBERG, MD | Tel-Aviv Sourasky Medical Center |
More Information
| Responsible Party: | Michal Roll PhD,MBA, division of research and development TASMC, Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01326403 History of Changes |
| Other Study ID Numbers: |
TASMC-11-ES-0129-CTIL |
| Study First Received: | March 21, 2011 |
| Last Updated: | June 6, 2012 |
Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
|
proximal hip fractures |
Additional relevant MeSH terms:
|
Fractures, Bone Hip Fractures Fractures, Closed Wounds and Injuries Femoral Fractures Hip Injuries Leg Injuries |
Tranexamic Acid Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |
ClinicalTrials.gov processed this record on August 18, 2017